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

Model Number	ISERT 230 (+24.00 D)
Medical Device Problem Code	Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/17/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
Date of implant: (b)(6) 2021.Date of event: (b)(6) 2021.Post-operative complication; glistening.It was confirmedt hat there was no loss of best corrected visual acuity for this patient; lens remains implanted in patients eye.
Additional Manufacturer Narrative
This initial emdr is being submitted to fda as a reportable event that occurred in the usa.Lens opacification (incl.Glistening) is indicated as a potential malfunction related to the iol, as covered under the warnings section of the product's instructions for use (ifu).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
Date of implant: (b)(6) 2021.Date of event: 17-sep-2021.Post-operative complication: glistening.It was confirmedt hat there was no loss of best corrected visual acuity for this patient: lens remains implanted in patient's eye.
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.The product was not returned to the manufacturer.The investigation was conducted, with the methods and results as noted below.No videos were available for the investigation.The product was not returned, and appearance check could not be performed.No abnormalities were found in production and inspection records of the product.(serial no.: (b)(6); model: 230).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.; 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: 14881408
• Report Number: 3006723646-2022-00083
• Device Sequence Number: 17682824
• Product Code: HQL
• UDI-Device Identifier: 04547480301396
• UDI-Public: 04547480301396
• Combination Product (Y/N): N
• Initial Reporter State: KS
• Initial Reporter Country: US
• PMA/510(K) Number: P080004
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted 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): 06/02/2022

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 (+24.00 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: 06/02/2022
• Supplement Date Received by Manufacturer: 06/02/2022
• Initial Report FDA Received Date: 06/30/2022
• Supplement Report FDA Received Date: 07/08/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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: Other
• Patient Sex: Unknown