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

Model Number	251 (+21.50 D)
Medical Device Problem Code	Material Split, Cut or Torn (4008)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	07/01/2020
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, 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 due to remarks made by the fda auditor during a pre-approval inspection of the new thailand facility from 03-06 april 2023.Therefore, a us fda emdr report is being submitted to correct this omission.Haptic damage is indicated as a potential malfunction related to the iol, as covered 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.As product was not returned appearance check could not be performed.No abnormalities were found in production and inspection records of the product.(serial no.: tbj400x5; 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 vietnam.Originally assessed as not reportable to local authorities.Ovd used was reported as "unknown." damaged haptic after implantation problem code: a0414 material split cut or torn implant date: (b)(6) 2020.Explant date: (b)(6) 2020.Patient impact: device explantation.

• 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: goutham pendyala ; 110 progress; suite 175; irvine, CA 92618 ; 9093896317
• MDR Report Key: 17297466
• Report Number: 3006723646-2023-00125
• Device Sequence Number: 3874792
• Product Code: HQL
• UDI-Device Identifier: 04547480450322
• UDI-Public: 04547480450322
• Combination Product (Y/N): N
• Initial Reporter Country: VM
• PMA/510(K) Number: P080004
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Device Explanted Year: 2020
• 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): 07/10/2023

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 04/30/2022
• Device Model Number: 251 (+21.50 D)
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/07/2021
• Initial Report FDA Received Date: 07/11/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 04/30/2019
• 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