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

Model Number NC1-SP (+ 20.00 D)

Device Problem Sharp Edges (4013)

Patient Problem Capsular Bag Tear (2639)

Event Date 07/11/2023

Event Type  Injury  

Manufacturer Narrative

This initial and final emdr is being submitted to fda for outside us like products reporting.Portions of the product were returned to the manufacturer.The investigation was conducted, with the methods and results as noted below.Injector was available for investigation.The iol was ejected out and wasn't returned.No abnormalities were found in production and inspection records of the product.(serial no: (b)(6); model: nc1-sp).Trace of lubricant (hpmc) was found inside the injector.The exact root cause of the event was not determined.From our investigation, we believe this event was not caused by our product quality.A review of the 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 germany.It was noted that hpmc was used intra-operative complications, posterior capsule rupture, imdrf code: a051102: share edges reportedly, injector caused capsule rupture on anterior capsule leaf when pulled out.Upon deployment of the iol there was a capsular rupture in the posterior capsule leaflet.Upon pulling out the injector there was a capsular rupture near the rexis at the anterior capsular leaflet.The lens was not explanted.Patient health impact: minor injury.

• Brand Name: NC1-SP
• 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: 17627977
• MDR Text Key: 322020013
• Report Number: 3006723646-2023-00418
• Device Sequence Number: 1
• Product Code: HQL
• Combination Product (y/n): N
• Reporter Country Code: GM
• 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
• Report Date: 08/25/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/25/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: NC1-SP (+ 20.00 D)
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/31/2023
• Date Manufacturer Received: 07/13/2023
• Was Device Evaluated by Manufacturer?: Yes
• 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): Required Intervention