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

Model Number	250 (+ 21.5 D)
Medical Device Problem Code	Material Split, Cut or Torn (4008)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	08/17/2023
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.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).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 malaysia.Damaged haptic after implantation.Imdrf code: a0414, material split cut or torn.Product replaced with another lens immediately during surgery.Wound stretch; increased incision size.Iol was explanted on (b)(6) 2023.
Event or Problem Description
Event occurred in malaysia.Damaged haptic after implantation.Imdrf code: a0414, material split cut or torn.Product replaced with another lens immediately during surgery.Wound stretch; increased incision size.Iol was explanted on (b)(6) 2023.
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.Appearance check result was consistent to reported information.No abnormalities were found in production and inspection records of the product.(serial no.: "(b)(6)" ; model: "250").We also confirmed there were not any abnormalities on the "loop pull strength test" of the material lot.("sovj-g115-30").From our investigation, we confirmed the reported event.No root cause was determined based on findings of investigation result.However, based on available information, we believe this event was not caused by our product quality.Capa-22-0009 has been initiated for damaged haptics complaints.

• 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: 18188554
• Report Number: 3006723646-2023-00449
• Device Sequence Number: 15272725
• Product Code: HQL
• UDI-Device Identifier: 04547480480817
• UDI-Public: 04547480480817
• 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): 01/17/2024

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: 10/31/2025
• Device Model Number: 250 (+ 21.5 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: 11/21/2023
• Supplement Report FDA Received Date: 01/17/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/31/2022
• 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