MAUDE Adverse Event Report: HOYA SURGICAL OPTICS, INC. PY-60AD; INTRAOCULAR LENS

Model Number PY-60AD (+ 23 D)

Device Problem Fracture (1260)

Patient Problem Failure of Implant (1924)

Event Date 11/27/2023

Event Type  Injury  

Manufacturer Narrative

This initial emdr is being submitted to fda for a complaint that occurred outside the usa for a like product reporting.Cracked or deformed cartridge/tip 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 section h6 - manufacturer's codes for: type of investigation, findings, and conclusion are pending 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

Event occurred in china.Cracked or deformed cartridge/tip.Cracked or broken optic.Product replaced with another lens immediately during surgery.Product was explanted on (b)(6) 2023.Product defect code: a040101, fracture.

Manufacturer Narrative

This follow-up report # 1 emdr is being submitted to fda for a reportable event that occurred outside the usa.The report includes corrected and additional information not available/included in the initial report.Corrected information: corrected to yes additional information: type of report - noted as follow-up #1 type of follow-up - noted for correction and additional information added codes for manufacturer's investigation: type; findings; and conclusion.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: py-60ad.The dye test result showed the injector tip was properly coated.The lens release test result showed that the re-installed new iol could be released out of the returned cartridge/tip without any problems.The 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.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.

Event Description

Event occurred in china cracked or deformed cartridge/tip.Cracked or broken optic.Product replaced with another lens immediately during surgery.Product was explanted on (b)(6) 2023 product defect code: a040101, fracture.

• Brand Name: PY-60AD
• Type of Device: INTRAOCULAR LENS
• Manufacturer (Section D): HOYA SURGICAL OPTICS, INC.; 110 progress; suite 175; 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 ; 110 progress; suite 175; irvine, CA 92618 ; 9093896317
• MDR Report Key: 18419752
• MDR Text Key: 331621857
• Report Number: 3006723646-2023-00469
• Device Sequence Number: 1
• Product Code: HQL
• Combination Product (y/n): N
• Reporter Country Code: CH
• 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: 04/09/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/29/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: PY-60AD (+ 23 D)
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 12/21/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/31/2023
• 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