MAUDE Adverse Event Report: HOYA SURGICAL OPTICS, INC. 254; INTRAOCULAR LENS

Model Number 254 (+20.00 D)

Device Problem Fracture (1260)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 09/15/2021

Event Type  Injury  

Manufacturer Narrative

The event occurred in (b)(6) and was initially determined as not reportable to the competent authorities in the region.However, as part of an internal review, the event has been re-assessed as a reportable event in finland and subsequently reported to their competent authorities.Therefore, this initial and final emdr is being submitted to fda for this as a reportable event that occurred outside the usa.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).The product was not returned to the manufacturer.The investigation was conducted, with the methods and results as noted below.Trend analysis was conducted.This complaint rate is within established threshold value and the customer does not require an investigation report.Exact root cause was not determined.However, based on available information, 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

Reportedly, a split cartridge / tip occurred.According to the reporter, there was an increase incision that required sutures to be closed.The lens remained into the patient's eye after clinical assessment.Patient condition and symptoms: no clinical signs, symptoms or conditions.

• Brand Name: 254
• Type of Device: INTRAOCULAR LENS
• Manufacturer (Section D): HOYA SURGICAL OPTICS, INC.; 15335 fairfield ranch rd.; suite 250; chino hills CA 91709
• Manufacturer (Section G): HOYA MEDICAL SINGAPORE PTE LTD; 455a jalan ahmad ibrahim; singapore, singapore 63993 9; SN 639939
• Manufacturer Contact: goutham pendyala ; 15335 fairfield ranch rd.; suite 250; chino hills, CA 91709 ; 9093896317
• MDR Report Key: 14431938
• MDR Text Key: 293171644
• Report Number: 3006723646-2022-00048
• Device Sequence Number: 1
• Product Code: HQL
• Combination Product (y/n): N
• Reporter Country Code: FI
• 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: 09/20/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/18/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/31/2022
• Device Model Number: 254 (+20.00 D)
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 09/20/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/31/2019
• 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