iSert Intraocular LensRecalls & reported problems across all models
Hoya Medical Singapore Pte. Ltd. · 69 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 264
- Deaths reported
- 0
- Injuries reported
- 211
- Recalls
- 0
We found 69 models of iSert Intraocular Lens by Hoya Medical Singapore Pte. Ltd. in the FDA's device registry (GUDID). Together they are named in 264 adverse event reports in the FDA's MAUDE database, received between Dec 1, 2015 and Sep 15, 2026 — classified as 211 injuries, 53 malfunctions.
The most frequently reported specific device problem is “Material Split, Cut or Torn” (74 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. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works
Reports received per month, all models
Most reported iSert Intraocular Lens problems
Device problems
- Material Split, Cut or Torn74
- Break67
- Adverse Event Without Identified Device or Use Problem16
- Appropriate Device Problem Term/Code Not Available14
- Device Appears to Trigger Rejection12
- Crack9
- Inaccurate Information9
- Insufficient Device Problem Information7
Patient problems
- Failure of Implant85
- No Known Impact Or Consequence To Patient63
- No Clinical Signs, Symptoms or Conditions22
- Visual Impairment18
- Capsular Bag Tear17
- No Code Available11
- No Information7
- Uveitis7
iSert Intraocular Lens models
69 models, most reported first. Each model has its own page with its reports, recalls and device details.
- iSert Intraocular Lens 250 (clear), +21.00DIntraocular Lens18 reports
- iSert Intraocular Lens 250 (clear), +22.50DIntraocular Lens17 reports
- iSert Intraocular Lens 251 (yellow), +20.50DIntraocular Lens11 reports
- iSert Intraocular Lens 250 (clear), +19.50DIntraocular Lens11 reports
- iSert Intraocular Lens 250 (clear), +22.00DIntraocular Lens11 reports
- iSert Intraocular Lens 250 (clear), +20.00DIntraocular Lens10 reports
- iSert Intraocular Lens 250 (clear), +19.00DIntraocular Lens9 reports
- iSert Intraocular Lens 250 (clear), +20.50DIntraocular Lens9 reports
- iSert Intraocular Lens 250 (clear), +21.50DIntraocular Lens9 reports
- iSert Intraocular Lens 250 (clear), +23.00DIntraocular Lens8 reports
- iSert Intraocular Lens 251 (yellow), +21.50DIntraocular Lens7 reports
- iSert Intraocular Lens 251 (yellow), +22.00DIntraocular Lens7 reports
- iSert Intraocular Lens 250 (clear), +18.00DIntraocular Lens7 reports
- iSert Intraocular Lens 250 (clear), +23.50DIntraocular Lens7 reports
- iSert Intraocular Lens 250 (clear), +18.50DIntraocular Lens6 reports
- iSert Intraocular Lens 251 (yellow), +18.00DIntraocular Lens5 reports
- iSert Intraocular Lens 251 (yellow), +21.00DIntraocular Lens5 reports
- iSert Intraocular Lens 251 (yellow), +23.00DIntraocular Lens5 reports
- iSert Intraocular Lens 251 (yellow), +17.50DIntraocular Lens4 reports
- iSert Intraocular Lens 251 (yellow), +19.50DIntraocular Lens4 reports
- iSert Intraocular Lens 250 (clear), +16.50DIntraocular Lens4 reports
- iSert Intraocular Lens 250 (clear), +17.50DIntraocular Lens4 reports
- iSert Intraocular Lens 250 (clear), +24.00DIntraocular Lens4 reports
- iSert Intraocular Lens 250 (clear), +24.50DIntraocular Lens4 reports
- iSert Intraocular Lens 230 (clear), +16.00DIntraocular Lens3 reports
- iSert Intraocular Lens 230 (clear), +20.00DIntraocular Lens3 reports
- iSert Intraocular Lens 230 (clear), +21.00DIntraocular Lens3 reports
- iSert Intraocular Lens 251 (yellow), +16.00DIntraocular Lens3 reports
- iSert Intraocular Lens 251 (yellow), +19.00DIntraocular Lens3 reports
- iSert Intraocular Lens 251 (yellow), +20.00DIntraocular Lens3 reports
- iSert Intraocular Lens 251 (yellow), +22.50DIntraocular Lens3 reports
- iSert Intraocular Lens 251 (yellow), +23.50DIntraocular Lens3 reports
- iSert Intraocular Lens 250 (clear), +14.00DIntraocular Lens3 reports
- iSert Intraocular Lens 250 (clear), +15.00DIntraocular Lens3 reports
- iSert Intraocular Lens 250 (clear), +25.50DIntraocular Lens3 reports
- iSert Intraocular Lens 230 (clear), +14.50DIntraocular Lens2 reports
- iSert Intraocular Lens 230 (clear), +17.00DIntraocular Lens2 reports
- iSert Intraocular Lens 230 (clear), +19.00DIntraocular Lens2 reports
- iSert Intraocular Lens 230 (clear), +22.00DIntraocular Lens2 reports
- iSert Intraocular Lens 251 (yellow), +24.00DIntraocular Lens2 reports
- iSert Intraocular Lens 251 (yellow), +25.00DIntraocular Lens2 reports
- iSert Intraocular Lens 251 (yellow), +25.50DIntraocular Lens2 reports
- iSert Intraocular Lens 250 (clear), +13.00DIntraocular Lens2 reports
- iSert Intraocular Lens 250 (clear), +17.00DIntraocular Lens2 reports
- iSert Intraocular Lens 250 (clear), +25.00DIntraocular Lens2 reports
- iSert Intraocular Lens 250 (clear), +26.00DIntraocular Lens2 reports
- iSert Intraocular Lens 230 (clear), +16.50DIntraocular Lens1 report
- iSert Intraocular Lens 230 (clear), +18.00DIntraocular Lens1 report
- iSert Intraocular Lens 230 (clear), +21.50DIntraocular Lens1 report
- iSert Intraocular Lens 230 (clear), +22.50DIntraocular Lens1 report
- iSert Intraocular Lens 230 (clear), +24.00DIntraocular Lens1 report
- iSert Intraocular Lens 230 (clear), +25.50DIntraocular Lens1 report
- iSert Intraocular Lens 230 (clear), +29.00DIntraocular Lens1 report
- iSert Intraocular Lens 231 (yellow), +20.00DIntraocular Lens1 report
- iSert Intraocular Lens 251 (yellow), +11.00DIntraocular Lens1 report
- iSert Intraocular Lens 251 (yellow), +13.50DIntraocular Lens1 report
- iSert Intraocular Lens 251 (yellow), +14.50DIntraocular Lens1 report
- iSert Intraocular Lens 251 (yellow), +15.50DIntraocular Lens1 report
- iSert Intraocular Lens 251 (yellow), +16.50DIntraocular Lens1 report
- iSert Intraocular Lens 251 (yellow), +17.00DIntraocular Lens1 report
- iSert Intraocular Lens 251 (yellow), +24.50DIntraocular Lens1 report
- iSert Intraocular Lens 251 (yellow), +28.50DIntraocular Lens1 report
- iSert Intraocular Lens 251 (yellow), +30.00DIntraocular Lens1 report
- iSert Intraocular Lens 250 (clear), +6.00DIntraocular Lens1 report
- iSert Intraocular Lens 250 (clear), +9.50DIntraocular Lens1 report
- iSert Intraocular Lens 250 (clear), +14.50DIntraocular Lens1 report
- iSert Intraocular Lens 250 (clear), +26.50DIntraocular Lens1 report
- iSert Intraocular Lens 250 (clear), +29.50DIntraocular Lens1 report
- iSert Intraocular Lens 250 (clear), +30.00DIntraocular Lens1 report
Recent iSert Intraocular Lens adverse event reports
The 15 most recent reports across all models, in the reporter's own words as published by the FDA.
InjurySep 15, 2026Device Contaminated During Manufacture or Shipping
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50781859 ↗InjuryJul 31, 2026Material Split, Cut or Torn
Event occurred in China.Damaged haptic after/during implantation.The patient underwent cataract surgery with implantation of an intraocular lens (IOL). After the IOL was injected and implanted during the procedure, it was noted that the distal end of the posterior haptic had fractured. The broken haptic fragment remained inside the injector, resulting in loss of integrity of the implanted IOL's posterior haptic.Subsequent examination revealed no retained intraocular foreign body and no evidence of ocular structural damage at present. However, there remains a potential risk of IOL decentration/dislocation and capsular bag instability.Problem Code: A0414 - Material Split, Cut or Torn.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50108010 ↗InjuryMay 28, 2026Material Split, Cut or Torn
EVENT OCCURRED IN CHINA. DAMAGED HAPTIC AFTER IMPLANTATION AS WE CHECKED WITH THE HOSPITAL, THERE WAS NO MORE INFORMATION FOR THIS CASE, THE HOSPITAL CAN NOT CONFIRM WHICH HAPTIC WAS DAMAGED, THE ENGLISH TRANSLATION OF THIS INITIAL REPORT IS THAT A PRELOADED ASPHERIC POSTERIOR CHAMBER INTRAOCULAR LENS (IOL) WAS DELIVERED TO THE OPERATING ROOM BY THE NURSE. DURING THE SURGICAL PROCEDURE, THE SURGEON IDENTIFIED THAT THE IOL HAPTIC WAS BROKEN, WHICH SERIOUSLY IMPACTED THE SURGICAL PROCESS. AND AFTER WE RECHECKED AGAIN, THE INCIDENT WAS INITIALLY REPORTED BY THE ADMIN IN THE HOSPITAL, BUT NOT THE SURGEON, SO INITIAL INFORMATION WAS WRONG. AN ADVERSE EVENT REPORTED IN MARCH BY (B)(6) HOSPITAL, S/N: (B)(6) AFTER COMMUNICATION WITH THE OPERATING SURGEON, IT WAS REPORTED THAT DURING IMPLANTATION, A SLIGHT FRACTURE WAS OBSERVED IN THE BLUE-COLORED PORTION OF THE HAPTIC. THE SURGEON ATTEMPTED TO IMPLANT THE LENS, BUT IT WAS FOUND THAT IT COULD NOT BE PROPERLY SUPPORTED WITHIN THE CAPSULAR BAG. THEREFORE, THE IOL WAS CUT AND REMOVED. IOL WAS EXPLANTED ON (B)(6) 2026 PROBLEM CODE: A0414 - MATERIAL SPLIT, CUT OR TORN
Patient problems: Failure of Implant
MAUDE report 25326166 ↗InjuryApr 15, 2026Sharp Edges
EVENT OCCURRED IN CHINA. AFTER IMPLANTATION OF THE INTRAOCULAR LENS INTO THE CAPSULAR BAG, A POSTERIOR CAPSULE RUPTURE WAS NOTED. REPEATED REVIEW OF THE SURGICAL VIDEO SUGGESTED A SUSPICION THAT THE POSTERIOR CAPSULE WAS TORN BY THE IOL HAPTIC. CURRENTLY, THE INTRAOCULAR LENS REMAINS WELL POSITIONED, INTRAOCULAR PRESSURE IS NORMAL, AND VISUAL ACUITY IS 0.4. CLOSE FOLLOW-UP WILL BE CONDUCTED. CAPSULAR BAG TEAR / RUPTURE. PRODUCT REMAINED IN EYE AFTER CLINICAL ASSESSMENT. PATIENT HEALTH NOT IMPACTED PROBLEM CODE: A051102 - SHARP EDGES.
Patient problems: Capsular Bag Tear
MAUDE report 24891884 ↗InjuryMar 4, 2026Sharp Edges
EVENT OCCURRED IN CHINA. LEADING; CAPSULAR BAG TEAR / RUPTURE; PATIENT HEALTH NOT IMPACTED. THE PATIENT, (B)(6), UNDERWENT PHACOEMULSIFICATION WITH INTRAOCULAR LENS IMPLANTATION UNDER TOPICAL ANESTHESIA ON (B)(6) 2026. DURING THE IMPLANTATION PROCESS, THE ANTERIOR HAPTIC OF THE INTRAOCULAR LENS TORE THE POSTERIOR CAPSULE WHILE UNFOLDING. AFTER ADJUSTING THE POSITION OF THE INTRAOCULAR LENS, IT WAS CENTERED IN THE CAPSULAR BAG. THE SURGERY WAS COMPLETED SMOOTHLY WITH NO ADVERSE EFFECTS. ALTHOUGH WE REQUESTED THE HOSPITAL TO PROVIDE SURGICAL PHOTOS, NO PICTURES OR VIDEOS WERE AVAILABLE FOR THE INVESTIGATION. PROBLEM CODE: A051102 - SHARP EDGES.
Patient problems: Capsular Bag Tear
MAUDE report 24510716 ↗InjuryFeb 27, 2026Material Split, Cut or Torn
EVENT OCCURRED IN MALAYSIA. DAMAGED HAPTIC AFTER IMPLANTATION. TRAILING; MIDDLE; DAMAGED HAPTIC. WOUND STRETCH; INCREASED INCISION SIZE. PRODUCT REPLACED WITH ANOTHER LENS IMMEDIATELY DURING SURGERY. PATIENT HEALTH NOT IMPACTED. IOL WAS EXPLANTED ON (B)(6) 2025. PROBLEM CODE: A0414 - MATERIAL SPLIT, CUT OR TORN.
Patient problems: Failure of Implant
MAUDE report 24466412 ↗InjuryFeb 27, 2026Material Split, Cut or Torn
EVENT OCCURRED IN MALAYSIA. DAMAGED HAPTIC AFTER IMPLANTATION. TRAILING; MIDDLE; DAMAGED HAPTIC. WOUND STRETCH; INCREASED INCISION SIZE. PRODUCT REPLACED WITH ANOTHER LENS IMMEDIATELY DURING SURGERY. PATIENT HEALTH NOT IMPACTED. IOL WAS EXPLANTED ON (B)(6) 2025. PROBLEM CODE: A0414 - MATERIAL SPLIT, CUT OR TORN.
Patient problems: Failure of Implant
MAUDE report 24466364 ↗InjuryFeb 18, 2026Crack
EVENT OCCURRED IN CHINA. DAMAGED OPTIC AFTER IMPLANTATION. CRACKED OR BROKEN OPTIC (MIDDLE). PATIENT HEALTH NOT IMPACTED. IOL WAS EXPLANTED ON (B)(6) 2025. PROBLEM CODE: A0404 - CRACK.
Patient problems: Failure of Implant
MAUDE report 24382664 ↗InjuryFeb 11, 2026Sharp Edges
EVENT OCCURRED IN CHINA. LEADING HAPTIC REPORTED. CAPSULAR BAG TEAR RUPTURE. THE PATIENT UNDERWENT PHACOEMULSIFICATION AND INTRAOCULAR LENS IMPLANTATION UNDER TOPICAL ANESTHESIA ON (B)(6) 2026. DURING THE IMPLANTATION, THE LEADING HAPTIC OF THE INTRAOCULAR LENS TORE THE POSTERIOR CAPSULE WHILE UNFOLDING. AFTER ADJUSTING THE POSITION OF THE INTRAOCULAR LENS AND INSTILLING CARBACHOL TO CONSTRICT THE PUPIL, THE IOL WAS CENTERED IN THE CAPSULAR BAG. THE SURGERY WAS COMPLETED SMOOTHLY WITH NO ADVERSE EFFECTS. PLEASE REFER TO THE ATTACHMENT SURGICAL PICTURE. PROBLEM CODE: A051102 - SHARP EDGES.
Patient problems: Capsular Bag Tear
MAUDE report 24318964 ↗InjuryJan 20, 2026Material Split, Cut or Torn
EVENT OCCURRED IN CHINA. DAMAGED HAPTIC AFTER IMPLANTATION. THE CAUSE WAS THAT AN INSUFFICIENT AMOUNT OF VISCOELASTIC WAS INJECTED DURING SURGERY, WHICH RESULTED IN THE HAPTIC BEING CLAMPED BEFORE THE LENS IMPLANTATION. THE SURGEON THEN FORCIBLY PUSHED THE LENS FORWARD, CAUSING THE INJECTOR TIP TO FRACTURE. AFTER DISCOVERING THE BROKEN HAPTIC, THE SURGEON REMOVED THE LENS AND IMPLANTED A NEW ONE. CURRENTLY, THE PATIENT HAS NOT EXPERIENCED ANY ADVERSE CONDITIONS POSTOPERATIVELY. PRODUCT REPLACED WITH ANOTHER LENS IMMEDIATELY DURING SURGERY; PATIENT HEALTH NOT IMPACTED; IOL WAS EXPLANTED ON (B)(6) 2025. PROBLEM CODE: A0414 - MATERIAL SPLIT, CUT OR TORN.
Patient problems: Failure of Implant
MAUDE report 24126035 ↗InjuryJan 5, 2026Insufficient Device Problem Information
EVENT OCCURRED IN CHINA. THE HAPTIC PUNCTURED AND RUPTURED THE CAPSULE AFTER IMPLANTING THE INTRAOCULAR LENS (IOL) INTO THE CAPSULAR BAG, A POSTERIOR CAPSULE RUPTURE WAS DISCOVERED. IT WAS SUSPECTED THAT THE IOL HAPTIC HAD TORN THE POSTERIOR CAPSULE. IN THIS CASE, THE RUPTURE WAS RELATIVELY SMALL, AND DURING FOLLOW-UP NO VITREOUS PROLAPSE, ELEVATED INTRAOCULAR PRESSURE, OR LENS DISPLACEMENT HAS BEEN OBSERVED. CLOSE FOLLOW-UP WILL CONTINUE. CAPSULAR BAG TEAR / RUPTURE; POSTERIOR CAPSULE RUPTURE; PROBLEM CODE: A26 - INSUFFICIENT DEVICE PROBLEM INFORMATION.
Patient problems: Capsular Bag Tear
MAUDE report 23968258 ↗InjuryJan 5, 2026Sharp Edges
EVENT OCCURRED IN CHINA. POSTERIOR CAPSULE RUPTURE AFTER IMPLANTING THE IOL INTO THE CAPSULAR BAG ON (B)(6), A POSTERIOR CAPSULE RUPTURE WAS OBSERVED. UPON REPEATED REVIEW OF THE SURGICAL VIDEO, IT WAS SUSPECTED THAT THE HAPTIC TORE THE POSTERIOR CAPSULE. IN THIS CASE, THE RUPTURE WAS EXTENSIVE. ONE WEEK AFTER SURGERY, SIGNIFICANT IOL DISLOCATION WAS NOTED, AND ON NOVEMBER 13, AN IOL REPOSITIONING SURGERY WAS PERFORMED. THE IOL IS CURRENTLY IN PLACE, INTRAOCULAR PRESSURE IS NORMAL, AND THE PATIENT WILL CONTINUE TO BE CLOSELY MONITORED. PRODUCT REMAINED IN EYE AFTER CLINICAL ASSESSMENT; PATIENT HAS RECOVERED AND IS FINE; RELPOSITIONING SURGERY PROBLEM CODE: A051102 - SHARP EDGES.
Patient problems: Insufficient Information
MAUDE report 23967928 ↗InjuryDec 11, 2025Material Split, Cut or Torn; Material Split, Cut or Torn
EVENT OCCURRED IN CHINA. DAMAGED HAPTIC AFTER IMPLANTATION. THE PATIENT UNDERWENT RIGHT EYE VITRECTOMY WITH DISLOCATED INTRAOCULAR LENS (IOL) REMOVAL AND SECONDARY IOL IMPLANTATION WITH SCLERAL FIXATION (USING A PRELOADED ASPHERIC POSTERIOR CHAMBER IOL) ON (B)(6) 2025, AT 15:00. THE PROCEDURE WAS PERFORMED WITHOUT SURGICAL CONTRAINDICATIONS AND COMPLETED SUCCESSFULLY. POSTOPERATIVE DAY 1 EXAMINATION REVEALED NO IOL ABNORMALITIES. HOWEVER, ON POSTOPERATIVE DAY 2, IOL DISPLACEMENT WAS OBSERVED, AND MYDRIATIC EXAMINATION IDENTIFIED A NASAL HAPTIC FRACTURE. CONSEQUENTLY, A RIGHT EYE IOL EXPLANTED AND REPLACED ANOTHER IOL WITH SCLERAL FIXATION WAS PERFORMED ON (B)(6) 2025. IOL WAS EXPLANTED ON (B)(6) 2025. PROBLEM CODE: A0414 - MATERIAL SPLIT, CUT OR TORN.
Patient problems: Failure of Implant
MAUDE report 23785898 ↗InjuryDec 3, 2025Optical Decentration; Optical Decentration
EVENT OCCURRED IN CHINA. THE PATIENT, WHO HAD SUFFERED FROM PROGRESSIVE VISUAL IMPAIRMENT IN THE RIGHT EYE FOR OVER 2 YEARS AND WAS IN THE MATURE STAGE OF CATARACT, UNDERWENT PHACOEMULSIFICATION AND INTRAOCULAR LENS (IOL) IMPLANTATION IN THE RIGHT EYE AT OUR HOSPITAL ON (B)(6) 2025. ON THE FIRST POSTOPERATIVE DAY ((B)(6) 2025), THE PATIENT WAS CONSCIOUS, IN GOOD SPIRITS, AND HAD NO DISCOMFORT SUCH AS EYE PAIN OR HEADACHE. PHYSICAL EXAMINATION REVEALED CONJUNCTIVAL CONGESTION, CORNEAL ENDOTHELIAL EDEMA AND FOLDS, A NORMAL ANTERIOR CHAMBER DEPTH, A PUPIL DIAMETER OF 2.5 MM, AND A WELL-POSITIONED IOL WITH GOOD REFLECTION. THE PATIENT REQUESTED DISCHARGE AND WAS DISCHARGED ACCORDINGLY. ON THE MORNING OF THE SECOND POSTOPERATIVE DAY ((B)(6) 2025), THE PATIENT RETURNED TO OUR OUTPATIENT CLINIC COMPLAINING OF PAIN IN THE OPERATED EYE. THE INTRAOCULAR PRESSURE WAS FOUND TO BE ELEVATED, AND THE IOL WAS DISLOCATED INFEROTEMPORALLY. THE PHYSICIAN ADMINISTERED 250 ML OF 20% MANNITOL INTRAVENOUSLY TO LOWER THE INTRAOCULAR PRESSURE, AND THE PATIENT WAS SUBSEQUENTLY TRANSFERRED TO ANOTHER HOSPITAL FOR FURTHER TREATMENT. AT THE EXTERNAL HOSPITAL, THE PATIENT UNDERWENT "VITRECTOMY AND IOL REPOSITIO
Patient problems: Failure of Implant
MAUDE report 23711783 ↗InjuryOct 16, 2025Material Split, Cut or Torn; Material Split, Cut or Torn
EVENT OCCURRED IN CHINA. DAMAGED HAPTIC AFTER IMPLANTATION. TRAILING; DAMAGED HAPTIC. "THE HOSPITAL REPORTED THE INCIDENT AS A SERIOUS ADVERSE EVENT TO CHINA AUTHORITY. DUE TO THE PATIENT'S ADVANCED AGE, ANOTHER IOL COULD NOT BE REPLACED, AND THE ORIGINAL ONE REMAINED IN THE EYE AFTER CLINICAL ASSESSMENT. THE PATIENT RETURNED THE NEXT DAY FOR FOLLOW-UP, AND THE IOL WAS CONFIRMED TO BE PROPERLY POSITIONED." THE SURGICAL IMAGE CAN BE FOUND IN THE ATTACHMENT. PROBLEM CODE: A0414 - MATERIAL SPLIT, CUT OR TORN.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23319199 ↗
Other Hoya Medical Singapore Pte. Ltd. products
All Hoya Medical Singapore Pte. Ltd. devices →Sources and updates
- Models: FDA GUDID, file dated Oct 13, 2026. Models are grouped by the brand name the manufacturer registered.
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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