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

Model Number	250 (+20.50 D)
Medical Device Problem Code	Device Appears to Trigger Rejection (1524)
Health Effect - Clinical Code	Toxic Anterior Segment Syndrome (TASS) (4469)
Date of Event	12/10/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
This initial and final emdr is being submitted to fda for a reportable event that occurred outside the usa.The delay in reporting was due to the complaint being originally assessed as "not reportable" to the regional regulatory authority in india, and the us facility's incorrect understanding that only complaints assessed as "reportable" in the region of origin, would need to undergo additional review for potential reportability to us fda.The error was noted by the fda auditor during a pre-approval inspection of the new thailand facility from 03-06 april 2023.Report # (b)(4).Therefore, a us fda emdr report is being submitted to correct this omission.The product was not returned to the manufacturer.The investigation was conducted, with the methods and results as noted below.As product was not returned appearance check could not be performed.Post operative inflammation summary (pois) form was not returned from surgeon.No abnormalities were found in production and inspection records of the product.(serial no.: (b)(6); model: 250).There were not any abnormalities on the sterilization records of the lot.(tl020).From our investigation, we couldn't confirm the reported event.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 india.Originally assessed as not reportable per mvpi india guideline, 11-03-2020.Ovd used was reported as "unknown." toxic anterior segment syndrome (tass) was reported.Implant date: (b)(6) 2021; onset > 5 days after implantation.Patient impact: patient has recovered and is fine.

• Brand Name: 250
• Common Device Name: INTRAOCULAR LENS
• Manufacturer (Section D): HOYA SURGICAL OPTICS, INC.; 525 technology dr.; suite 280; irvine CA 92618
• Manufacturer (Section G): HOYA MEDICAL SINGAPORE PTE LTD; 455a jalan ahmad ibrahim; singapore, singapore 63993 9; SN 639939
• MDR Report Key: 17015035
• Report Number: 3006723646-2023-00057
• Device Sequence Number: 20742443
• Product Code: HQL
• UDI-Device Identifier: 04547480480794
• UDI-Public: 04547480480794
• Combination Product (Y/N): N
• Initial Reporter Country: IN
• PMA/510(K) Number: P080004
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 04/12/2023

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 Expiration Date: 03/31/2024
• Device Model Number: 250 (+20.50 D)
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/20/2021
• Initial Report FDA Received Date: 05/26/2023
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/31/2021
• 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