SofPort® IOL LI61AO (REF LI61AOR2000)Recalls & reported problems
Bausch & Lomb Incorporated · SofPort Silicone Advanced Optics Aspheric Lens +20.00D · 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 10757770474315), received between Jun 22, 2023 and Apr 2, 2025 — classified as 2 injuries.
The most frequently reported specific device problem is “Material Twisted/Bent” (2 reports).
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
- Material Twisted/Bent2
Patient problems
- No Clinical Signs, Symptoms or Conditions1
- Vitreous Loss1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
InjuryApr 2, 2025Material Twisted/Bent; Material Twisted/Bent
IT WAS REPORTED THAT AFTER THE IMPLANTATION OF AN INTRAOCULAR LENS (IOL) INTO THE LEFT EYE, A BENT HAPTIC WAS NOTICED. THE INCISION WAS ENLARGED FOR THE REMOVAL OF THE IOL, A BACK UP LENS WAS IMPLANTED, AND THE WOUND WAS CLOSED WITH NYLON SUTURES. OUTCOME OF THE PATIENT IS GOOD.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21752080 ↗InjuryJun 22, 2023Material Twisted/Bent; Material Twisted/Bent
IT WAS REPORTED THAT WHILE PERFORMING A COMBINED INTRAOCULAR LENS (IOL) EXCHANGE AND VITRECTOMY PROCEDURE, DURING IMPLANTATION OF THE IOL INTO THE LEFT EYE, IT WAS OBSERVED THAT THE LEADING HAPTIC WAS BENT BEYOND REPAIR. THE IOL WAS REMOVED. SMALL ZONULAR DIALYSIS WAS OBSERVED WITH VITREOUS LOSS. A VITRECTOMY WAS PERFORMED, AND A SUCCESSFUL LENS EXCHANGE WAS PERFORMED POSITIONING A BACKUP THREE-PIECE LENS IN THE CILIARY SULCUS. IN THE SURGEON'S OPINION, THE MOST LIKELY CAUSE OF THE IOL DAMAGE WAS THE DELIVERY DEVICE WHICH ALLEGEDLY LED TO THE BENT HAPTIC. PATIENT OUTCOME IS GOOD. ADDITIONAL INFORMATION WAS REQUESTED, BUT NOT RECEIVED.
Patient problems: Vitreous Loss
MAUDE report 17184700 ↗
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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