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

Model Number HOYA ISERT 250 (+22.0 D)

Device Problem Optical Decentration (1360)

Patient Problem Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 03/08/2018

Event Type  Injury  

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.The product was not available for the investigation.No abnormalities were found in production and inspection records of the product.Exact root cause is not determined.

Event Description

Returned implant card states "lens became dislocated in the eye - will be removed at a later date." distributor made several attempts to gather more information, but was unsuccessful.No other information available.Date explanted is not known.

• Brand Name: HOYA ISERT 250
• 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, 63993 9; SN 639939
• Manufacturer Contact: goutham pendyala ; 15335 fairfield ranch rd.; suite 250; chino hills, CA 91709 ; 9093896317
• MDR Report Key: 11038485
• MDR Text Key: 222394850
• Report Number: 3006723646-2020-00021
• Device Sequence Number: 1
• Product Code: HQL
• UDI-Device Identifier: 04547480480824
• UDI-Public: 04547480480824
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P080004
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,health profession
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 06/07/2018

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
• Device Operator: Health Professional
• Device Expiration Date: 01/31/2020
• Device Model Number: HOYA ISERT 250 (+22.0 D)
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/07/2018
• Initial Date FDA Received: 12/18/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/31/2017
• 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