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

Model Number	250 (+ 20 D)
Medical Device Problem Code	Failure to Eject (4010)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	08/18/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
Event occurred in malaysia.Iol got stuck during screw rotation due to injector malfunction during iol insertion.Imdrf code: a050301, failure to eject.Iol was explanted on (b)(6) 2023.
Additional Manufacturer Narrative
This initial emdr is being submitted to fda for an event that occurred outside of the usa.Injector malfunction 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.
Additional Manufacturer Narrative
This follow-up #1 emdr is being submitted to fda for an event that occurred outside of the usa.The report includes additional information not available/included in the initial report.The product was returned to the manufacturer.The investigation was conducted, with the methods and results as noted below.Potential harm of this complaint category is defined as "negligible" or "minor", and the complaint rate doesn't reach its action/alert level.In addition, this is not a customer letter/ae report required case.So, we completed this process with trend analysis and appearance check.Appearance check result was consistent to reported information.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 malaysia.Iol got stuck during screw rotation due to injector malfunction during iol insertion imdrf code: a050301, failure to eject.Iol was explanted on (b)(6) 2023.

• 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: goutham pendyala ; 110 progress; suite 175; irvine, CA 92618 ; 9093896317
• MDR Report Key: 18196907
• Report Number: 3006723646-2023-00451
• Device Sequence Number: 17743225
• Product Code: HQL
• UDI-Device Identifier: 04547480480787
• UDI-Public: 04547480480787
• Combination Product (Y/N): N
• Initial Reporter Country: MY
• 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): 01/18/2024

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: 01/31/2026
• Device Model Number: 250 (+ 20 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: 11/06/2023
• Supplement Date Received by Manufacturer: 11/06/2023
• Initial Report FDA Received Date: 11/22/2023
• Supplement Report FDA Received Date: 01/18/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/31/2023
• 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
• Patient Sex: Unknown