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

Model Number	PREVUE C (+17.00 D)
Medical Device Problem Code	Material Split, Cut or Torn (4008)
Health Effect - Clinical Codes	Failure of Implant (1924); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/07/2022
Type of Reportable Event	Malfunction
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 haptics pushed out of the wand and the lens was not able to be inserted, the lens was explanted due to broken haptic.No incision enlargement; product replaced with another lens immediately during surgery; the procedure was notcomplicated in any way.The backup iol was successfully implanted and patient outcome is good.Patient health not impacted.
Additional Manufacturer Narrative
This follow-up #1 emdr is being submitted to fda for a reportable event that occurred inside of the usa.The report includes corrected information and additional information not available/included in the initial report.H6 - no added codes for manufacturer's investigation: type; findings; and conclusion - as this event has been re-assessed as not reportable based on clarifications received from distributor 23-jan-2023.
Event or Problem Description
Initial reported information was: damaged haptic after implantation.The haptics pushed out of the wand and the lens was not able to be inserted, the lens was explanted due to broken haptic.No incision enlargement; product replaced with another lens immediately during surgery; the procedure was not complicated in any way.The backup iol was successfully implanted and patient outcome is good.Patient health not impacted.Per 23-jan-2023 corrected information received: the lens was not inserted into the eye.The event "happened right before they were going to insert the lens." there was patient contact but no injury; they were not able to insert the lens.Based on corrected information: complaint category revised to: damaged haptic before implantation.Complaint reporting assessment revised to: not reportable - because there was no injury, no intra-operative explant, and no delay insurgery.However, a follow-up emdr is required to correct the reporting as the corrected information was received after the initial emdr was submitted.

• Brand Name: PREVUE C
• 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: 16118998
• Report Number: 3006723646-2023-00002
• Device Sequence Number: 5753853
• Product Code: HQL
• UDI-Device Identifier: 10757770564092
• UDI-Public: 10757770564092
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• 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): Unknown
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 12/08/2022

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: 11/30/2023
• Device Model Number: PREVUE C (+17.00 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: 12/08/2022
• Supplement Date Received by Manufacturer: 12/08/2022
• Initial Report FDA Received Date: 01/08/2023
• Supplement Report FDA Received Date: 02/09/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/30/2020
• 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; Other
• Patient Sex: Unknown