iSert Intraocular Lens 230 (clear), +29.00DRecalls & reported problems
Hoya Medical Singapore Pte. Ltd. · Class 3 · Implant
All models of iSert Intraocular Lens (69)
Data updated Oct 18, 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 04547480301495), received between Aug 6, 2018 and Aug 6, 2018 — classified as 1 injury.
The most frequently reported specific device problem is “Optical Decentration” (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
- Optical Decentration1
Patient problems
- Visual Disturbances1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryAug 6, 2018Optical Decentration; Optical Decentration
PER THE DATA COLLECTION FORM: ORIGINAL MULTIFOCAL IMPLANTATION [FROM A DIFFERENT MANUFACTURER] CREATED SIGNIFICANT GLARE AND HALOS; ORIGINAL SURGERY DATE OS, (B)(6) 2016. IOL EXCHANGE MONOFOCAL [FROM THIS MANUFACTURER] FOR MULTIFOCAL - DATE OF SURGERY (B)(6) 2017. DATE OF ONSET/PROBLEM: (B)(6) 2017. PROBLEM/EVENT: LENS EXCHANGE MULTIFOCAL FOR MONOFOCAL OS; LENS PLACED IN SULCUS OS; MODERATE BUT STABLE INFERIOR CENTRATION, OPTIC STILL WITHIN UNDILATED PUPIL CAUSING SYMPTOMS OF INTERMITTENT MONOCULAR DIPLOPIA. INFERIOR DECENTRATION OS, NOTED (B)(6) 2017. SECONDARY SURGICAL INTERVENTION IS PENDING IOL EXCHANGE OS FOR ANOTHER MONOFOCAL IN SULCUS. SURGEON IN PROCESS OF RESEARCHING MONOFOCAL SULCUS LENS OPTIONS FOR 2ND MONOFOCAL EXCHANGE PROCEDURE - TBD. IN THE SURGEON'S OPINION, THE LIKELY CAUSE OF THE EVENT: CHANGES TO THE INTEGRITY OF THE SULCUS AND CAPSULE RELATED TO IMPLANTATION THEN SUBSEQUENT EXCHANGE OF ORIGINAL MULTIFOCAL IOL OS. PATIENT'S PROGNOSIS & TREATMENT: GOOD PROGNOSIS. TBD WHICH MONOFOCAL MODEL TO BE USED IN SECOND LENS EXCHANGE OS.
Patient problems: Visual Disturbances
MAUDE report 7754285 ↗
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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