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

Model Number PC-60R (+ 19.50 D)

Device Problem Fracture (1260)

Patient Problem Failure of Implant (1924)

Event Date 01/13/2021

Event Type  Injury  

Event Description

Event occured in malaysia.Originally assessed as not reportable to local authorities.Problem code: a040101 fracture.Implant date: (b)(6) 2021.Explant date: (b)(6) 2021.Patient impact: device explantation.

Manufacturer Narrative

This initial and final emdr is being submitted to fda for a reportable event that occurred outside the usa.The delay in reporting was due to the complaint being originally assessed as "not reportable" to the regional regulatory authority, and the us facility's incorrect understanding that only complaints assessed as "reportable" in the region of origin, would need to undergo additional review for potential reportability to us fda.The error was noted due to remarks made by the fda auditor during a pre-approval inspection of the new thailand facility from (b)(6) 2023.Therefore, a us fda emdr report is being submitted to correct this omission.The device was not returned to the manufacturer.The investigation was conducted, with the methods and results as noted below.No abnormalities were found in the production and inspection records of the product.(serial no.:(b)(6); model: pc-60r).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.

• Brand Name: PC-60R
• 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: 17417139
• MDR Text Key: 320021344
• Report Number: 3006723646-2023-00294
• Device Sequence Number: 1
• Product Code: HQL
• Combination Product (y/n): N
• Reporter Country Code: MY
• PMA/PMN Number: P080004
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,User Facility,Company Representative,Distributor
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 07/26/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/28/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Model Number: PC-60R (+ 19.50 D)
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/27/2021
• Date Manufacturer Received: 05/06/2021
• Was Device Evaluated by Manufacturer?: Yes
• 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