MAUDE Adverse Event Report: HOYA SURGICAL OPTICS, INC. NC1-SP; INTRAOCULAR LENS

Model Number NC1-SP (+19.50 D)

Device Problems Optical Distortion (3000); Appropriate Term/Code Not Available (3191)

Patient Problem Insufficient Information (4580)

Event Date 08/23/2022

Event Type  Injury  

Manufacturer Narrative

This initial and final emdr is being submitted to fda for a reportable event that occurred outside the usa.Posterior capsule opacification (pco) is indicated as a potential adverse event related to iol implantation as covered under the warnings section of the product's instructions for use (ifu).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 production and inspection records of the product.(serial no.: (b)(4) model: nc1-sp).There were no abnormalities on the sterilization records of the lot.(eq026).Exact root cause was not determined.However, from our investigation, we believe the event is not related to 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 reported in austria.Post-operative complications - pco.Reported as 9 months after implantation.Patient impact: unknown; insufficient information.

Manufacturer Narrative

This follow-up #1 emdr is being submitted to fda for a reportable event that occurred outside the usa.Event occurred in austria and was initially assessed as a reportable event based on the available reported information.After an individual medical assessment was conducted, corrections to the initial report were noted as outlined below.Updated information as of (b)(6) 2022 indicated that no negative impact on the patient's health occurred.The patient had expressed concerns about avoiding a pco after his recent iol implantation.Therefore, the event has been re-assessed as not reportable in austria, the country of origin.

Event Description

Event reported in austria.Date of implant - not provided.Post-operative complications - pco.Reported as 9 months after implantation.Patient impact: unknown; insufficient information.(b)(6) 2022 updated information with reportability reassessed to not reportable in austria, as noted below.Post operative complications, after-cataract, were previously reported.(b)(6) 2022: the case will be assessed non-reportable as no patient impact was reported and the main patient's questions and concern had been addressed by individual medical assessment.Per individual medical assessment: the patient's main concern was about avoiding a pco after his recent iol implantation.This concern was addressed.Pco is a known potential ae and treatable.No negative impact on patient's health was reported.Malfunctions and defects of the devices are being monitored.All trends, when observed, are and will be reported.

• Brand Name: NC1-SP
• Type of Device: INTRAOCULAR LENS
• Manufacturer (Section D): HOYA SURGICAL OPTICS, INC.; 525 technology drive; suite 280; 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 ; 525 technology drive; suite 280; irvine, CA 92618 ; 9093896317
• MDR Report Key: 15407526
• MDR Text Key: 299761501
• Report Number: 3006723646-2022-00134
• Device Sequence Number: 1
• Product Code: HQL
• Combination Product (y/n): N
• Reporter Country Code: AU
• PMA/PMN Number: P080004
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Consumer,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 08/23/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/12/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 01/31/2023
• Device Model Number: NC1-SP (+19.50 D)
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 08/23/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/31/2020
• 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