MAUDE Adverse Event Report: HOYA SURGICAL OPTICS, INC. HOYA FC-60AD; INTRAOCULAR LENS

Model Number	HOYA FC-60AD (+22.50 D)
Medical Device Problem Code	Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Codes	Blurred Vision (2137); Eye Pain (4467)
Date of Event	07/25/2017
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.Serial number: (b)(4) - no abnormalities were found in production and inspection records of the product.Exact root cause is not determined for this case.From our investigation, we believe this issue is not product related.
Event or Problem Description
Dr.(b)(6) implanted both lenses.One lens was implanted on the left eye on (b)(6) 2017 (serial number (b)(4) - previous complaint) and the other on (b)(6) 2017 (serial number (b)(4) - this complaint).It was reported that the patient has experienced pressure behind the eye, headaches, sensitivity and blurry vision when looking at a items at a distance.Patient returned twice to his doctor, the doctor tells him to use the eye drops.No other information is available.

• Brand Name: HOYA FC-60AD
• 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: 11038497
• Report Number: 3006723646-2020-00023
• Device Sequence Number: 16459987
• Product Code: HQL
• UDI-Device Identifier: 04547480104096
• UDI-Public: 04547480104096
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: P080004
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor
• Initial Reporter Occupation: 505
• Type of Report: Initial
• Report Date (Section B): 09/14/2017

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: 10/31/2020
• Device Model Number: HOYA FC-60AD (+22.50 D)
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/14/2017
• 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: Other