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

Model Number	ISERT 230 (+25.50 D)
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/16/2022
Type of Reportable Event	Malfunction
Event or Problem Description
Cracked or deformed cartridge/tip.Iol got stuck in the nozzle during insertion; lens injector tip cracked during insertion.Lens was still able to be implanted.No incision enlargement, but sutures were required.Patient condition: no clinical signs, symptoms or conditions.Health impact: modified surgical procedure, prolonged surgery.
Additional Manufacturer Narrative
This initial emdr is being submitted to fda as a reportable event that occurred in the usa.Injector malfunction is indicated as a potential malfunction related to the injector system, 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.
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.Portions of the product were returned to the manufacturer.The investigation was conducted, with the methods and results as noted below.The injector was returned.The iol was not returned.No abnormalities were found in production and inspection records of the product.(serial no.: (b)(6); model:230).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 tip 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.
Event or Problem Description
Cracked or deformed cartridge/tip.Iol got stuck in the nozzle during insertion; lens injector tip cracked during insertion.Lens was still able to be implanted.No incision enlargement, but sutures were required.Patient condition: no clinical signs, symptoms or conditions.Health impact: modified surgical procedure, prolonged surgery.

• Brand Name: ISERT 230
• Common Device Name: INTRAOCULAR LENS
• Manufacturer (Section D): HOYA SURGICAL OPTICS, INC.; 525 technology drive; suite 280; 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 ; 525 technology drive; suite 280; irvine, CA 92618 ; 9093896317
• MDR Report Key: 14712251
• Report Number: 3006723646-2022-00099
• Device Sequence Number: 11328706
• Product Code: HQL
• UDI-Device Identifier: 04547480301426
• UDI-Public: 04547480301426
• Combination Product (Y/N): N
• Initial Reporter State: AR
• Initial Reporter Country: US
• PMA/510(K) Number: P080004
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative,Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 05/18/2022

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: 10/31/2022
• Device Model Number: ISERT 230 (+25.50 D)
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/18/2022
• Supplement Date Received by Manufacturer: 05/18/2022
• Initial Report FDA Received Date: 06/16/2022
• Supplement Report FDA Received Date: 07/06/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/31/2019
• 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