Reported Jul 29, 2015 · Terminated
Bausch & Lomb SoFlex SE Foldable intraocular Lens Product Usage: The SofPort/SoFlex IOLs are intended for primary…
Bausch & Lomb Surgical, Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Bausch & Lomb Surgical, Inc. · 21 N Park Place Blvd · Clearwater, FL · 33759-3917
Is this the product you have?
- Bausch & Lomb SoFlex SE
- Foldable intraocular Lens Product UsageThe SofPort/SoFlex IOLs are intended for primary implantation in the capsular bag of the eye for the visual correction of aphakia secondary to the removal of a cataractous lens in adult patients
- Lot codes and dates
- Produce CodeLI61AO and LI61SE. LOT #'s 4455501, 4455723, 4456117, 4456118, 4456123, 4456207, 4456213, 4456214, 4456306, 4456316, 4456318, 4456319, 4456403, 4456406, 4456412, 4456413, 4456414, 4456415, 4456416, 4456703, 4456704, 4456707, 4456710, 4456711, 4456712, 4456713, 4456714, 4456715, 4456716, 4456717, 4456718, 4456719, 4456720, 4456721, 4456722, 4456723, 4456724, 4456725, 4456726, 4456727, 4456801, 4456803, 4456804, 4456805, 4456807, 4456808, 4456809, 4456810, 4456811, 4456812, 4456813, 4456814, 4456815, 4456816, 4456817, 4456818, 4456819, 4456820, 4456821, 4456822, 4456823, 4456824, 4456825, 4456826, 4456827, 4456828, 4456829, 4456830, 4456831, 4456832, 4456901, 4456902, 4456903, 4456904, 4456905, 4456906, 4456907, 4456908, 4456909, 4456910, 4456911, 4456912, 4457001, 4457002, 4457003, 4457004, 4457005, 4457006, 4457007, 4457008, 4457009, 4457010, 4457011, 4457012, 4457013, 4457014, 4457015, 4457016, 4457017, 4457018, 4457019, 4457020, 4457021, 4457022, 4457101, 4457102, 4457103, 4457104, 4457105, 4457106, 4457107, 4457108, 4457109, 4457110, 4457111, 4457401, 4457402, 4457403, 4457404, 4457406, 4457407, 4457408, 4457409, 4457410, 4457411, 4457412, 4457413, 4457414, 4457415, 4457416, 4457417, 4457418, 4457419, 4457420, 4457421, 4457422, 4457423, 4457424, 4457426, 4457427, 4457428, 4457501, 4457502, 4457503, 4457504, 4457505, 4457506, 4457507, 4457508, 4457509, 4457510, 4457511, 4457512, 4457513, 4457514, 4457515, 4457516, 4457517, 4457518, 4457519, 4457520, 4457521, 4457522, 4457523, 4457601, 4457602, 4457603, 4457604, 4457606, 4457607, 4457608, 4457609, 4457610, 4457611, 4457612, 4457613, 4457614, 4457615, 4457616, 4457617, 4457618, 4457619, 4457620,
856 of 856 codes
445770144577024457703445770444577054457706445770744577084457709445771044577114457712445771344577144457715445771644577174457718445771944577204457721445772244577234457724445772544577264457727445780144578024457803445780444578054457806445780744578084457809445781044578114457812445781344578144457815445781644578174457818445781944578204457821445782244581014458102445810344581044458105445810644581074458108445810944581104458111
- Produce CodeLI61AO and LI61SE. LOT #'s 4455501, 4455723, 4456117, 4456118, 4456123, 4456207, 4456213, 4456214, 4456306, 4456316, 4456318, 4456319, 4456403, 4456406, 4456412, 4456413, 4456414, 4456415, 4456416, 4456703, 4456704, 4456707, 4456710, 4456711, 4456712, 4456713, 4456714, 4456715, 4456716, 4456717, 4456718, 4456719, 4456720, 4456721, 4456722, 4456723, 4456724, 4456725, 4456726, 4456727, 4456801, 4456803, 4456804, 4456805, 4456807, 4456808, 4456809, 4456810, 4456811, 4456812, 4456813, 4456814, 4456815, 4456816, 4456817, 4456818, 4456819, 4456820, 4456821, 4456822, 4456823, 4456824, 4456825, 4456826, 4456827, 4456828, 4456829, 4456830, 4456831, 4456832, 4456901, 4456902, 4456903, 4456904, 4456905, 4456906, 4456907, 4456908, 4456909, 4456910, 4456911, 4456912, 4457001, 4457002, 4457003, 4457004, 4457005, 4457006, 4457007, 4457008, 4457009, 4457010, 4457011, 4457012, 4457013, 4457014, 4457015, 4457016, 4457017, 4457018, 4457019, 4457020, 4457021, 4457022, 4457101, 4457102, 4457103, 4457104, 4457105, 4457106, 4457107, 4457108, 4457109, 4457110, 4457111, 4457401, 4457402, 4457403, 4457404, 4457406, 4457407, 4457408, 4457409, 4457410, 4457411, 4457412, 4457413, 4457414, 4457415, 4457416, 4457417, 4457418, 4457419, 4457420, 4457421, 4457422, 4457423, 4457424, 4457426, 4457427, 4457428, 4457501, 4457502, 4457503, 4457504, 4457505, 4457506, 4457507, 4457508, 4457509, 4457510, 4457511, 4457512, 4457513, 4457514, 4457515, 4457516, 4457517, 4457518, 4457519, 4457520, 4457521, 4457522, 4457523, 4457601, 4457602, 4457603, 4457604, 4457606, 4457607, 4457608, 4457609, 4457610, 4457611, 4457612, 4457613, 4457614, 4457615, 4457616, 4457617, 4457618, 4457619, 4457620,
- Amount recalled
- 72,773 units; 52,787 units (US) 19,986 units (Foreign)
This recall covers 2 products
The agency filed one notice per product. You are reading one of them; the other one is below.
Where it was sold
Why it was recalled
Haptics breaking during lens loading and insertion.
This product could cause temporary or reversible health problems — stop using it.
Want the full recall guide?
The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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