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

Model Number PREVUE C (+24.50 D)

Device Problem Material Split, Cut or Torn (4008)

Patient Problem Failure of Implant (1924)

Event Date 09/22/2022

Event Type  Injury  

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 Description

Damaged haptic after implantation.End of haptic blue part broken off in inserter.Lens had to be removed.Incision was not enlarged and no sutures used.Patient health not impacted.

Event Description

Damaged haptic after implantation.End of haptic blue part broken off in inserter.Lens had to be removed.Incision was not enlarged and no sutures used.Patient health not impacted.

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 product return g2 - indicated company representative for investigation 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.Portions of the product were returned to the manufacturer.The investigation was conducted, with the methods and results as noted below.Injector and haptic piece were available for investigation.Appearance check result was consistent to reported information.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.No abnormalities were found in production and inspection records of the product.(serial no.: (b)(6).; model: prevue c).There were not any abnormalities on the loop pull strength test record of the material lot.(sotb-115-05).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: PREVUE C
• Type of Device: 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: 15584493
• MDR Text Key: 301554169
• Report Number: 3006723646-2022-00145
• Device Sequence Number: 1
• Product Code: HQL
• UDI-Device Identifier: 10757770564245
• UDI-Public: 10757770564245
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P080004
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 09/27/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/11/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/30/2023
• Device Model Number: PREVUE C (+24.50 D)
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 09/27/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/30/2020
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention