iSymm Intraocular Lens FC-60AD (clear), +21.00DRecalls & reported problems
Hoya Medical Singapore Pte. Ltd. · Class 3 · Implant
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 04547480104065), received between Mar 1, 2016 and Apr 20, 2016 — classified as 2 malfunctions.
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. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.
Most reported problems
Device problems
- Break1
- Detachment Of Device Component1
- Material Deformation1
Patient problems
- Tissue Damage2
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionApr 20, 2016Material Deformation
REPORT STATED THAT THE SURGEON HAD TO ENLARGE THE INCISION TO EXPLANT THE IOL FROM THE PATIENT'S EYE. ANOTHER HOYA IOL WAS IMPLANTED AND NO SCHEDULING OF AN ADDITIONAL SURGERY WAS REQUIRED. THE PATIENT'S PROGNOSIS IS UNKNOWN AT THIS TIME AS NO ADDITIONAL INFORMATION WAS MADE AVAILABLE. CUSTOMER REPORTS THE MALFUNCTION AS A DEFORMED HAPTIC.
Patient problems: Tissue Damage
MAUDE report 5591740 ↗MalfunctionMar 1, 2016Break; Detachment Of Device Component
THE LENS LOADED FINE, DURING IMPLANTATION IT WAS NOTICED THAT THE TRAILING HAPTIC HAD SNAPPED OFF AS THE PLUNGER OF THE INSERTER HAD ADVANCED THE LENS. THERE WAS AN ENLARGEMENT OF THE INCISION WHEN EXPLANTED. THE LENS WAS EASILY REMOVED AFTERWARDS AND A NEW IOL WAS IMPLANTED.
Patient problems: Tissue Damage
MAUDE report 5471217 ↗
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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