SofPort® IOL LI61AO (REF LI61AOR2350)Recalls & reported problems
Bausch & Lomb Incorporated · SofPort Silicone Advanced Optics Aspheric Lens +23.50D · Class 3 · Implant
Data updated Oct 13, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10757770474384), received between Jan 22, 2020 and Jan 22, 2020 — classified as 1 injury.
The most frequently reported specific device problem is “Break” (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. How this data works · Data updated Oct 13, 2026.
Most reported problems
Device problems
- Break1
- Material Split, Cut or Torn1
Patient problems
- Blurred Vision1
- Capsular Bag Tear1
- Macular Edema1
- No Code Available1
- Vitrectomy1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryJan 22, 2020Break; Material Split, Cut or Torn; Break; Material Split, Cut or Torn
IT WAS REPORTED THAT WHILE INSERTING THE INTRAOCULAR LENS (IOL) THE END OF THE LEADING HAPTIC BROKE OFF. THE SURGEON WAS ABLE TO REMOVE THE PIECE OF HAPTIC, BUT THE SURGEON REPORTS IT CAUSED RIP IN THE POSTERIOR CAPSULAR BAG WITH LOSS OF VITREOUS, REQUIRING A VITRECTOMY. THE IOL WAS PLACED IN THE CILIARY SULCUS INSTEAD OF THE CAPSULAR BAG, WHICH WAS A CHANGE IN THE SURGERY PLAN. THE IOL DAMAGE WAS OBSERVED INTRAOPERATIVELY. THE SURGEON BELIEVES THE IOL IS DEFECTIVE. THE INCISION WAS NOT ENLARGED, AND NO SUTURES WERE REQUIRED. THE LENS REMAINS IMPLANTED. THE PATIENTS VISION APPEARS TO BE RECOVERING WELL. THERE IS STILL VITREOUS IN THE ANTERIOR CHAMBER, SO THE SURGEON IS CONCERNED ABOUT THE DEVELOPMENT OF CYSTOID MACULAR EDEMA. THE PATIENT WILL BE RETURNING FOR A FINAL POSTOPERATIVE EVALUATION.
Patient problems: Blurred Vision; Capsular Bag Tear; Macular Edema; No Code Available; Vitrectomy
MAUDE report 9615679 ↗
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 13, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 13, 2026
- Page last rebuilt: Oct 13, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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