SofPort® IOL LI61AO (REF LI61AOR1750)Recalls & reported problems
Bausch & Lomb Incorporated · SofPort Silicone Advanced Optics Aspheric Lens +17.50D · Class 3 · Implant
All models of SofPort IOL (20)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 2
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10757770474261), received between May 4, 2023 and Apr 18, 2024 — classified as 2 injuries.
The most frequently reported specific device problem is “Material Twisted/Bent” (1 report).
Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.
Reports received per month
Most reported problems
Device problems
- Adverse Event Without Identified Device or Use Problem1
- Material Twisted/Bent1
Patient problems
- Capsular Bag Tear1
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
InjuryApr 18, 2024Material Twisted/Bent; Material Twisted/Bent
REPORTEDLY, DURING IMPLANTATION OF AN INTRAOCULAR LENS (IOL) INTO THE EYE, IT WAS NOTICED THAT A HAPTIC WAS BENT. THE INCISION WAS ENLARGED, THE IOL WAS REMOVED, AND A BACKUP LENS WAS IMPLANTED WITH NO ADVERSE EVENT NOTED. ADDITIONAL INFORMATION WAS REQUESTED, BUT NOT RECEIVED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19134459 ↗InjuryMay 4, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT AN INTRAOCULAR LENS (IOL) WAS IMPLANTED AND REMOVED INTRAOPERATIVELY DUE TO AN UNSTABLE CAPSULE. THE PATIENT REQUIRED A VITRECTOMY AND WAS LEFT APHAKIC. IT WAS REPORTED AN ANTERIOR PLACEMENT WILL BE NEEDED. ADDITIONAL INFORMATION WAS REQUESTED, BUT NOT RECEIVED.
Patient problems: Capsular Bag Tear
MAUDE report 16867450 ↗
Other Intraocular Lens devices
- TECNIS IOL PCB00Johnson & Johnson Surgical Vision, Inc. · intraocular lens146 reports
- TECNIS IOL PCB00Johnson & Johnson Surgical Vision, Inc. · intraocular lens145 reports
- TECNIS IOL PCB00Johnson & Johnson Surgical Vision, Inc. · intraocular lens144 reports
- TECNIS IOL PCB00Johnson & Johnson Surgical Vision, Inc. · intraocular lens139 reports
- TECNIS SIMPLICITY DIB00Johnson & Johnson Surgical Vision, Inc. · intraocular lens1 recall81 reports
- TECNIS IOL PCB00Johnson & Johnson Surgical Vision, Inc. · intraocular lens129 reports
- TECNIS IOL PCB00Johnson & Johnson Surgical Vision, Inc. · intraocular lens127 reports
- TECNIS IOL PCB00Johnson & Johnson Surgical Vision, Inc. · intraocular lens126 reports
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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