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

Model Number 255 (+18.00 D)

Device Problem Material Split, Cut or Torn (4008)

Patient Problem Failure of Implant (1924)

Event Date 09/27/2022

Event Type  Injury  

Event Description

Damaged haptic after implantation.The doctor found the trailing haptic was separated at tip and explanted the iol from the eye.The surgery was completed with a back up iol.

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).(b)(4).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.The doctor found the trailing haptic was separated at tip and explanted the iol from the eye.The surgery was completed with a back up iol.

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: h3 - corrected to yes.Additional information: g6 - type of report - noted as follow-up #1.The product was returned to the manufacturer.The investigation was conducted, with the methods and results as noted below.Appearance check result was consistent to reported information.No abnormalities were found in production and inspection records of the product.(serial no.: (b)(6) ; model: 255).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.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.Capa-22-0009 has been initiated for "damaged haptic" complaints.

• 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: 15596784
• MDR Text Key: 301663165
• Report Number: 3006723646-2022-00146
• 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: 09/28/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/13/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 255 (+18.00 D)
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 09/28/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/30/2021
• 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