MAUDE Adverse Event Report: HOYA SURGICAL OPTICS, INC. 255; INTRAOCULAR LENS

Model Number 255 (+19.50 D)

Device Problem Material Split, Cut or Torn (4008)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 12/01/2022

Event Type  malfunction  

Event Description

Damaged haptic after implantation.The iol remained in the eye though the trailing haptic was separated.The haptic piece remained in the injector.The patient's health was not impacted for now.

Manufacturer Narrative

This initial report is being submitted to fda for a reportable event that occurred outside 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).Regarding investigation summary- manufacturer's codes for: type of investigation, findings, and conclusion are pending the completion of the 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.

Manufacturer Narrative

This follow-up #1 emdr is being submitted to fda for a reportable event that occurred outside of the usa.The report includes corrected information and additional information not available/included in the initial report.Corrected information: d9 - corrected to yes h3 - corrected to yes additional information: d9 - added date returned 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.The haptic piece was not released into the eye.In the returned injector, the haptic piece was found between the nozzle and rod.No abnormalities were found in production and inspection records of the product.(serial no.: (b)(6).Model: 255).Dye test and release test results showed the tip was properly coated.Proper coating allows the lens to advance.Exact root cause was not determined.However, based on the available information and our investigation, we believe this event was not caused by our product quality.Capa-22-0009 has been initiated for "damaged haptic" complaints.

Event Description

Damaged haptic after implantation.The iol remained in the eye though the trailing haptic was separated.The haptic piece remained in the injector.The patient's health was not impacted for now.

• Brand Name: 255
• Type of Device: INTRAOCULAR LENS
• Manufacturer (Section D): HOYA SURGICAL OPTICS, INC.; 525 technology drive; suite 280; irvine CA 92618
• Manufacturer (Section G): HOYA CORPORATION; 6-10-1 nishi shinjuku; shinjuku-ku; tokyo, 160-0 023; JA 160-0023
• Manufacturer Contact: goutham pendyala ; 525 technology drive; suite 280; irvine, CA 92618 ; 9093896317
• MDR Report Key: 16030948
• MDR Text Key: 308172092
• Report Number: 3006723646-2022-00163
• Device Sequence Number: 1
• Product Code: HQL
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: P080004
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 12/01/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 255 (+19.50 D)
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 12/01/2022
• Initial Date FDA Received: 12/21/2022
• Supplement Dates Manufacturer Received: 12/01/2022
• Supplement Dates FDA Received: 01/08/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/30/2022
• 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): Other