The Recall Desk
Agency classClass IIOur severity:HighFDA (Devices)·Z-2154-2015·Announced 2015-07-29

Bausch & Lomb SoFlex SE Intraocular Lens Recall for Haptic Breakage

Bausch & Lomb is recalling SoFlex SE foldable intraocular lenses because haptics may break during loading and insertion.

The agency’s classification

FDA (Devices): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 3/5 (High).

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: The recall is classified as FDA Class II, and the hazard involves a structural failure of a medical device during a surgical procedure, which poses a risk of harm even though specific injury reports are not detailed in the provided text.

Plain-English summary

Bausch & Lomb Surgical, Inc. is recalling the SoFlex SE Foldable intraocular lens. The recall is due to a defect where the lens haptics may break during the loading and insertion process. These lenses are intended for primary implantation in the capsular bag of the eye to correct vision after cataract removal in adult patients.

The recall covers 72,773 units, with 52,787 units distributed in the United States and 19,986 units distributed in foreign countries. The affected products are identified by produce codes LI61AO and LI61SE and specific lot numbers listed in the official recall documentation. Distribution was worldwide, including all 50 US states, Puerto Rico, and numerous international markets.

Patients who have had these lenses implanted should contact their eye care professional for evaluation. The source text does not specify a consumer action for unopened units, but the defect is noted to occur during the surgical procedure of loading and insertion.

The recalled product

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.
Manufacturer
Bausch & Lomb Surgical, Inc.
Category
Medical Device — Intraocular Lens
Hazard

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (20)

  • 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

Distribution

Distributed nationwide across the United States.

The notice also names 42 states specifically:

Part of a larger recall action

This product is one of 2 recalled by Bausch & Lomb Surgical, Inc. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 2 products in this recall →

Related recalls

Same manufacturer · Bausch & Lomb Surgical, Inc.

See all →

Same hazard · structural failure

See all →

Similar recalls