iSert Intraocular Lens 251 (yellow), +23.00DRecalls & 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
- 5
- Deaths reported
- 0
- Injuries reported
- 2
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 04547480450353), received between Sep 12, 2016 and Jun 28, 2023 — classified as 2 injuries, 3 malfunctions.
The most frequently reported specific device problem is “Break” (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.
Most reported problems
Device problems
- Break2
- Crack1
- Material Split, Cut or Torn1
- Scratched Material1
Patient problems
- No Known Impact Or Consequence To Patient3
- Failure of Implant1
- No Code Available1
Recent adverse event reports
The 5 most recent of 5 reports, in the reporter's own words as published by the FDA.
InjuryJun 28, 2023Material Split, Cut or Torn; Material Split, Cut or Torn
EVENT OCCURRED IN VIETNAM. ORIGINALLY ASSESSED AS NOT REPORTABLE TO LOCAL AUTHORITIES. OVD USED WAS REPORTED AS "UNKNOWN." DAMAGED HAPTIC AFTER IMPLANTATION PROBLEM CODE: A0414 MATERIAL SPLIT, CUT OR TORN. IMPLANT DATE: (B)(6) 2020. EXPLANT DATE: (B)(6) 2020. PATIENT IMPACT: DEVICE EXPLANTATION.
Patient problems: Failure of Implant
MAUDE report 17218191 ↗InjuryJun 11, 2019Scratched Material; Scratched Material
INJECTOR WAS FILLED AS USUAL WITH METHOCEL. THE IOL COULD BE EASILY ADVANCED. IMPLANTATION AS USUAL - AFTER THE LENS DID FOLD PUNCTUAL DEEPENING (WRINKLE) ON THE LENS WAS OBSERVED. IOL WAS EXPLANTED. ANOTHER LENS HAS BEEN IMPLANTED.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 8689652 ↗MalfunctionJun 11, 2019Break; Break
LENS IMPLANTED AND DID NOT FEEL ANY STIFFER IN INJECTOR, HOWEVER NOTICED THERE WAS A TEAR IN THE OPTIC WHEN IMPLANTED IN THE BAG NEAR THE HAPTIC OPTIC JUNCTION. LENS LEFT IN SITU, SURGEON (B)(6) FOLLOWING PATIENT UP. NO KNOWN PATIENT CONSEQUENCES TO DATE.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 8689646 ↗MalfunctionOct 9, 2018Break; Break
PARTIAL SEPARATION OF PART OF THE TRAILING HAPTIC WAS NOTICED DURING IMPLANTATION. LENS HAD TO BE EXPLANTED. NEW LENS WAS IMPLANTED. SECOND IMPLANTATION WENT WELL WITHOUT HARMING THE PATIENT. PATIENT OUTCOME: NO PATIENT IMPACT.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 7948128 ↗MalfunctionSep 12, 2016Crack
REPORT STATED THAT THE SURGEON HAD TO ENLARGE THE INCISION TO 2.5MM FOR REMOVAL OF LENS. THIS EVENT OCCURED RIGHT AFTER IOL IMPLANTATION. THE PATIENT'S PROGNOSIS WAS REPORTED AS "RECOVERED." CUSTOMER REPORTS THE MALFUNCTION AS A "CRACKED HAPTIC."
Patient problems: No Code Available
MAUDE report 5943587 ↗
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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