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

Model Number	250 (+23.50 D)
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	11/02/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
Damaged haptic after implantation.Torn trailing haptic.Device explanted.Patient health not impacted; patient has recovered and is fine; no permanent or negative impact on patient health expected.
Additional Manufacturer Narrative
The event occurred in germany, but the event assessment was delayed in the region.The event has been assessed as a reportable event in germany and subsequently reported to their competent authorities.Therefore, this initial emdr is being submitted to fda for this as a reportable event that occurred outside 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).Manufacturer's codes for patient health effects (clinical and impact), and device problem and component have been entered in this report.Manufacturer's codes for investigation type, findings and conclusion are pending the completion of the product investigation.Once the investigation is completed, a follow-up report will be submitted to fda which will include the manufacturer's codes for investigation type, findings and conclusion.
Additional Manufacturer Narrative
This follow-up #1 emdr is being submitted to fda for a reportable event that occurred outside of the usa.The report includes corrected information and additional information not available/included in the initial report.Corrected information: d9 - corrected to no.Additional information: g6 - type of report - noted as follow-up #1.H2 - type of follow-up - noted for corrected information and additional information.H3 - indicated not returned.H6 - added codes for manufacturer's investigation: type; findings; and conclusion.The product was not 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: 250).We also confirmed there were not any abnormalities on the loop pull strength test record of the material lot.(soua-g115-02).The exact root cause of the event was not determined.However, based on available information, 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
Damaged haptic after implantation.Torn trailing haptic.Device explanted.Patient health not impacted; patient has recovered and is fine; no permanent or negative impact on patient health expected.

• Brand Name: 250
• Common Device Name: INTRAOCULAR LENS
• Manufacturer (Section D): HOYA SURGICAL OPTICS, INC.; 15335 fairfield ranch rd.; suite 250; chino hills CA 91709
• Manufacturer (Section G): HOYA MEDICAL SINGAPORE PTE LTD; 455a jalan ahmad ibrahim; singapore, singapore 63993 9; SN 639939
• Manufacturer Contact: goutham pendyala ; 15335 fairfield ranch rd.; suite 250; chino hills, CA 91709 ; 9093896317
• MDR Report Key: 14482013
• Report Number: 3006723646-2022-00088
• Device Sequence Number: 4736028
• Product Code: HQL
• UDI-Device Identifier: 04547480480855
• UDI-Public: 04547480480855
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: P080004
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Device Explanted Year: 2021
• 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): 11/09/2021

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: 03/31/2024
• Device Model Number: 250 (+23.50 D)
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/09/2021
• Supplement Date Received by Manufacturer: 11/09/2021
• Initial Report FDA Received Date: 05/24/2022
• Supplement Report FDA Received Date: 06/29/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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