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

Model Number PC-60R (22.50 D)

Device Problem Fracture (1260)

Patient Problem Insufficient Information (4580)

Event Date 05/02/2023

Event Type  malfunction  

Manufacturer Narrative

This initial emdr is being submitted to fda for outside us like products reporting.Injector malfunction is indicated as a potential malfunction related to the injector system, 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 brazil - per distributor, event reported by hospital directly to anvisa in brazil as a technical complaint.Cracked or deformed cartridge/tip; injector cracks during lens implantation in the eye.Patient impact: insufficient information.

Manufacturer Narrative

This follow-up #1 emdr is being submitted to fda for an event that occurred outside of the usa.The report includes corrected and additional information not available/included in the initial report.Corrected information: d9 - corrected to no.Additional information: g6 - type of report - noted as follow-up #1.H2 - type of follow-up - noted for corrected and additional information.H3 - indicated device not returned.H6 - added codes for manufacturer's investigation: type; findings; and conclusion.The product 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 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.

Event Description

Event occurred in brazil - per distributor, event reported by hospital directly to anvisa in brazil as a technical complaint.Cracked or deformed cartridge/tip; injector cracks during lens implantation in the eye.Patient impact: insufficient information.

• 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; suite175; irvine, CA 92618 ; 9093896317
• MDR Report Key: 17137251
• MDR Text Key: 317921846
• Report Number: 3006723646-2023-00090
• Device Sequence Number: 1
• Product Code: HQL
• Combination Product (y/n): N
• Reporter Country Code: BR
• PMA/PMN Number: P080004
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Company Representative,Distributor
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 06/14/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/15/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: PC-60R (22.50 D)
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 05/18/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/31/2022
• 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