MAUDE Adverse Event Report: Hoya Surgical Optics, Inc. 250; Intraocular Lens

Model Number	250 (+ 23 D)
Medical Device Problem Code	Device Contaminated During Manufacture or Shipping (2969)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/01/2026
Type of Reportable Event	Serious Injury

• 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 ; 110 progress; suite 175; irvine, CA 92618 ; +1(551)199-1123
• MDR Report Key: 50781859
• Report Number: 3006723646-2026-00053
• Device Sequence Number: 21502773
• Product Code: HQL
• UDI-Device Identifier: 04547480480848
• UDI-Public: 04547480480848
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: P080004
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility,Company Representative
• Type of Report: Initial
• Report Date (Section B): 08/28/2026

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 (+ 23 D)
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/28/2026
• Initial Report FDA Received Date: 09/15/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 02/28/2026
• 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