MAUDE Adverse Event Report: Hoya Surgical Optics, Inc. 251; Intraocular Lens

Model Number	251 (+ 22 D)
Medical Device Problem Code	Material Split, Cut or Torn (4008)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/02/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
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.
Additional Manufacturer Narrative
This initial emdr is being submitted to the 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).Regarding section h6 - manufacturer's codes for: type of investigation, findings, and conclusion are pending completion of product investigation.Once the product investigation is completed, a follow-up report will be submitted to fda which will include the manufacturer's codes for type of investigation, findings, and conclusion.

• Brand Name: 251
• 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: 50108010
• Report Number: 3006723646-2026-00050
• Device Sequence Number: 10216908
• Product Code: HQL
• UDI-Device Identifier: 04547480450339
• UDI-Public: 04547480450339
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: P080004
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2026
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility,Company Representative
• Type of Report: Initial,Followup
• Report Date (Section B): 07/17/2026

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: 251 (+ 22 D)
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/17/2026
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 07/31/2026
• Supplement Report FDA Received Date: 08/13/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 07/31/2025
• 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
• Patient Sex: Unknown