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

Model Number	250 (+ 21.5 D)
Medical Device Problem Code	Optical Decentration (1360)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	10/14/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
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 repositioning" in the right eye on (b)(6) 2025, and the procedure was completed successfully.Problem code: a0602 - optical decentration.
Additional Manufacturer Narrative
This initial report is being submitted to fda for a reportable event that occurred outside the usa.Intraocular pressure elevation 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.The product was not returned and appearance check was not performed.From information provided, the iol was dislocated on day 3.No abnormalities were found in production and inspection records of the product.(serial no.: (b)(6); model: 250).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: 23711783
• Report Number: 3006723646-2025-00082
• Device Sequence Number: 10275319
• Product Code: HQL
• UDI-Device Identifier: 04547480480817
• UDI-Public: 04547480480817
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: P080004
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 11/13/2025

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?: No
• Operator of Device: Health Professional
• Device Model Number: 250 (+ 21.5 D)
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/13/2025
• Initial Report FDA Received Date: 12/03/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/31/2025
• 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