MAUDE Adverse Event Report: HOYA SURGICAL OPTICS, INC. 250; INTRAOCULAR LENS

Model Number	250 (+ 21 D)
Medical Device Problem Code	Material Split, Cut or Torn (4008)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	03/10/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
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.
Additional Manufacturer Narrative
This initial report is being submitted to fda for a reportable event that occurred outside the usa.Haptic damage is indicated as a potential malfunction related to the iol, as stated under the warnings section of the product's instructions for use (ifu).The product was returned to the manufacturer.The investigation was conducted, with the methods and results as noted below.Appearance check result was consistent to reported information.The customer could not confirm whether this is leading or trailing.No abnormalities were found in production and inspection records of the product (serial no.: (b)(6); model: 250).We also confirmed there were not any abnormalities on the loop pull strength test record of the material lot (toed-g115-06).The dye test result showed the injector tip was properly coated.The lens release test result showed that the re-installed new iol could be released out of the returned cartridge/tip without any problems.The exact root cause was not determined.However, based on the available information and our investigation, we believe this event was not caused by our product quality.A review of the most recent complaint trending data indicates that no significant trends have been identified at this time and no capa is required as part of the product evaluation.

• Brand Name: 250
• Common Device Name: INTRAOCULAR LENS
• Manufacturer (Section D): HOYA SURGICAL OPTICS, INC.; 110 progress; suite 175; irvine CA 92618
• Manufacturer (Section G): HOYA MEDICAL SINGAPORE PTE LTD; 455a jalan ahmad ibrahim; singapore, singapore 63993 9; SN 639939
• Manufacturer Contact: ana paula lebkuchen geraldo ; 110 progress; suite 175; irvine, CA 92618
• MDR Report Key: 25326166
• Report Number: 3006723646-2026-00042
• Device Sequence Number: 9861188
• Product Code: HQL
• UDI-Device Identifier: 04547480480800
• UDI-Public: 04547480480800
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: P080004
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2026
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 05/22/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 250 (+ 21 D)
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/22/2026
• Initial Report FDA Received Date: 05/28/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/31/2025
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown