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

Model Number	251 (+19.5D)
Medical Device Problem Code	Material Twisted/Bent (2981)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	11/16/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
This initial emdr is being submitted to fda for an event that occurred outside of the usa.Deformed haptic is indicated as a potential malfunction related to the iol, as covered under the warnings section of the product's instructions for use (ifu).Regarding section h6 - manufacturer's codes for: type of investigation, findings, and conclusion are pending device return and completion of product investigation.Once the product investigation is completed, a follow-up report will be submitted to fda which will include the manufacturer's codes for type of investigation, findings, and conclusion.
Event or Problem Description
Event occurred in australia.Deformed haptic after implantation.There was possible to serious injury.Medical device problem: a040609, material twisted/bent.Iol was explanted on (b)(6) 2023.
Additional Manufacturer Narrative
This follow-up report #1 emdr is being submitted to fda for a reportable event that occurred outside the usa.The report includes corrected and additional information not available/included in the initial report.Corrected information: h3 - corrected to yes additional information: g6 - type of report - noted as follow-up #1 h2 - type of follow-up - noted for correction and additional information h6 - added codes for manufacturer's investigation: type; findings; and conclusion.The product was returned to the manufacturer.The investigation was conducted, with the methods and results as noted below.No abnormalities were found in production and inspection records of the product.(serial no.: (b)(6) ; model: 251).We also confirmed there were no abnormalities on the loop pull strength test record of the material lot.(tycf-g115-10).The dye test result showed the injector tip was properly coated.The lens release test result showed that the re-installed new iol could be released from the returned cartridge/tip and injector body without any problems.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 australia deformed haptic after implantation.There was possible to serious injury medical device problem: a040609, material twisted/bent iol was explanted on (b)(6) 2023.

• 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: 18414486
• Report Number: 3006723646-2023-00464
• Device Sequence Number: 16817046
• Product Code: HQL
• UDI-Device Identifier: 04547480450285
• UDI-Public: 04547480450285
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: P080004
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Device Explanted Year: 2023
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 03/19/2024

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: 06/30/2026
• Device Model Number: 251 (+19.5D)
• 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: 12/12/2023
• Supplement Date Received by Manufacturer: 12/12/2023
• Initial Report FDA Received Date: 12/28/2023
• Supplement Report FDA Received Date: 03/19/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/30/2023
• 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