MAUDE Adverse Event Report: HOYA SURGICAL OPTICS, INC. HOYA ISERT 250; INTRAOCULAR LENS

Model Number	HOYA ISERT 250 (+20.0 D)
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Visual Disturbances (2140)
Date of Event	03/08/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
As a part of our continuous monitoring and improvement efforts, this initial and final emdr is being submitted to fda as a reportable adverse event that occurred in the usa.The product was not returned.Therefore, the product investigation consisted of a review of the production and inspection records.The results of the investigation are listed below.As the product was not returned from the customer, visual inspection could not be performed, and further information could not be provided about the lens and the entire injector.No abnormalities were found in production and inspection records of the product.Exact root cause is not determined.From our investigation, we believe this issue is not product related.
Event or Problem Description
Cracked optic resulting in a vertical line through middle of optic.Plan is to exchange lens on march 23rd.It was reported that the surgeon has experienced some "cracking" in the iol after/during implantation.The surgeon shall be returning to the o.R, explanting the iol and replacing it with a different manufacturer's iol.This patient is now experiencing a "line" in their vision noted on looking at bright lights and headlights, although acuity is quite good and except for a linear defect in the implant everything looks excellent.The lens will be explanted on march 23rd.

• Brand Name: HOYA ISERT 250
• Common Device Name: INTRAOCULAR LENS
• Manufacturer (Section D): HOYA SURGICAL OPTICS, INC.; 15335 fairfield ranch rd.; suite 250; chino hills CA 91709
• MDR Report Key: 11038472
• Report Number: 3006723646-2020-00020
• Device Sequence Number: 1265261
• Product Code: HQL
• UDI-Device Identifier: 04547480480787
• UDI-Public: 04547480480787
• Combination Product (Y/N): N
• Initial Reporter State: MN
• Initial Reporter Country: US
• PMA/510(K) Number: P080004
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Device Explanted Year: 2017
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,health profession
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 03/17/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Expiration Date: 05/31/2023
• Device Model Number: HOYA ISERT 250 (+20.0 D)
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/17/2017
• Initial Report FDA Received Date: 12/18/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention