MAUDE Adverse Event Report: HOYA SURGICAL OPTICS, INC. 251; INTRAOCULAR LENS

Model Number	251 (+ 25.5 D)
Medical Device Problem Code	Sharp Edges (4013)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	11/03/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
This initial report is being submitted to fda for a reportable event that occurred outside the usa.Posterior capsule rupture is indicated as a potential adverse event related to iol implantation as stated under the warnings section of the product's instructions for use (ifu).The product was not returned to the manufacturer.The investigation was conducted, with the methods and results as noted below.We could not confirm the reported event from provided photo.The product was not returned.No abnormalities were found in production and inspection records of the product.(serial no.: tbq223d8; model: 251).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.
Event or Problem Description
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.

• 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: 23967928
• Report Number: 3006723646-2026-00001
• Device Sequence Number: 9215261
• Product Code: HQL
• UDI-Device Identifier: 04547480450407
• UDI-Public: 04547480450407
• 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 Implanted Year: 2025
• 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): 12/11/2025

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 (+ 25.5 D)
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/11/2025
• Initial Report FDA Received Date: 01/05/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 01/31/2025
• 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