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

Model Number	ISERT 251 (+28.50 D)
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	03/28/2022
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.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.No abnormalities were found in production and inspection records of the product.(serial no.: (b)(4); model: 251).In addition, research in our complaint database indicated there were not any similar complaints for the same production lot number.(ljw5014) exact root cause was not determined.However, from our investigation, we believe the event is not related to 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.A cracked or broken optic (in the middle), a damaged trailing haptic were reported.It was also reported that it was more difficult than usual (pushing or screwing the iol through the injector).The product was replaced with another lens immediately during surgery.Patient impact: explantation no permanent or negative impact on patient health expected.

• Brand Name: ISERT 251
• 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: 14181553
• Report Number: 3006723646-2022-00066
• Device Sequence Number: 4936174
• Product Code: HQL
• UDI-Device Identifier: 04547480450469
• UDI-Public: 04547480450469
• 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: 2022
• Device Explanted Year: 2022
• 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): 03/30/2022

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: 04/30/2024
• Device Model Number: ISERT 251 (+28.50 D)
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/30/2022
• Initial Report FDA Received Date: 04/22/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 04/30/2021
• 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