FDA Device recall Z-2154-2015

Bausch & Lomb SoFlex SE Foldable intraocular Lens Product Usage: The SofPort/SoFlex IOLs are intended for primary implantation in the capsu…

FDA Device
Class II
terminated
Published 2015-07-29

On 2015-07-29 the FDA classified a Class II recall of Bausch & Lomb SoFlex SE Foldable intraocular Lens Product Usage: The SofPort/SoFlex IOLs are intended for primary implantation in the capsu… by Bausch And Lomb Surgical, citing haptics breaking during lens loading and insertion.

Read the official FDA Device notice

Agency	FDA Device
Recall number	Z-2154-2015
Classification	Class II
Status	terminated
Initiated	2015-05-26
Published	2015-07-29
Last updated	2026-09-13 11:53 UTC
Company	Bausch And Lomb Surgical
Distribution	US

Product

Bausch & Lomb SoFlex SE Foldable intraocular Lens Product Usage: The 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.

Reason

Haptics breaking during lens loading and insertion.

Identifiers

code_info	Produce Code: LI61AO and LI61SE. LOT #'s 4455501, 4455723, 4456117, 4456118, 4456123, 4456207, 4456213, 4456214, 445… Produce Code: LI61AO 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,

code_info

Produce Code: LI61AO and LI61SE. LOT #'s 4455501, 4455723, 4456117, 4456118, 4456123, 4456207, 4456213, 4456214, 445…

Produce Code: LI61AO 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,

Status history

No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.

Source

Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2154-2015%22

RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.