MAUDE Adverse Event Report: HOYA SURGICAL OPTICS, INC. ISERT 230; INTRAOCULAR LENS

Model Number	ISERT 230 (+21.00 D)
Medical Device Problem Code	Material Twisted/Bent (2981)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	12/27/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
This initial emdr is being submitted to fda as a reportable event that occurred in 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: 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
Damaged haptic after implantation.The haptic was noted to be bent during insertion.The incision enlargement went from a 2.7mm to 3.0mm to remove the lens.Patient condition: failure of implant.Health impact: device explantation.
Event or Problem Description
Damaged haptic after implantation.The haptic was noted to be bent during insertion.The incision enlargement went from a 2.7mm to 3.0mm to remove the lens.Patient condition: failure of implant.Health impact: device explantation.
Additional Manufacturer Narrative
This follow-up #1 emdr is being submitted to fda for a reportable event that occurred in the usa.The report includes corrected information and additional information not available/included in the initial report.Corrected information: h3 -corrected to yes.Additional information: d9 - added date of return.G2 - indicated company representative (for investigation findings).G6 - type of report - noted as follow-up #1.H2 - type of follow-up - noted for corrected information and additional information.H6 - added codes for manufacturer's investigation: type; findings; and conclusion.Parts of the product were returned to the manufacturer.The investigation was conducted, with the methods and results as noted below.Only part of the lens with one deformed haptic attached, and the injector were returned.The reported broken haptic and the remaining portion of the explanted lens were not returned.Therefore, the appearance check result was partially consistent to reported information.But we could not confirm the reported broken haptic.No abnormalities were found in production and inspection records of the product.(serial no.: (b)(6).We also confirmed there were not any abnormalities on the loop pull strength test record of the material lot.(sosk-60-01) the dye test result showed the injector tip was properly coated.Proper coating allows the lens to advance.We could release a re-installed iol from the returned injector without any problems.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.

• Brand Name: ISERT 230
• 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: 13529364
• Report Number: 3006723646-2022-00023
• Device Sequence Number: 4040266
• Product Code: HQL
• UDI-Device Identifier: 04547480301334
• UDI-Public: 04547480301334
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• 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: Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 01/19/2022

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: 12/31/2022
• Device Model Number: ISERT 230 (+21.00 D)
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/05/2022
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/19/2022
• Supplement Date Received by Manufacturer: 01/19/2022
• Initial Report FDA Received Date: 02/14/2022
• Supplement Report FDA Received Date: 03/02/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/31/2019
• 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