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

Model Number	ISERT 250 (+18.50 OD)
Medical Device Problem Code	Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Code	Capsular Bag Tear (2639)
Date of Event	06/15/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Hoya device will not be returned for evaluation.(b)(4).
Event or Problem Description
It was reported that the lens haptic tore the capsular bag while being injected into the patient's eye.The lens was removed and replaced with another lens model.Additional information has been requested, but no additional information has been received.
Additional Manufacturer Narrative
As a part of our continuous monitoring and improvement efforts, this follow-up #1 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.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
It was reported that the lens haptic tore the capsular bag while being implanted into the patient's eye.The lens was removed and replaced with another lens model.Additional information has been requested, but no additional information has been received.

• Brand Name: HOYA ISERT 250
• Common Device Name: INTRAOCULAR LENS
• Manufacturer (Section D): HOYA SURGICAL OPTICS, INC.; 15335 fairfield ranch road; suite 250; chino hills CA 91709
• MDR Report Key: 6734385
• Report Number: 3006723646-2017-00014
• Device Sequence Number: 19000314
• Product Code: HQL
• UDI-Device Identifier: 04547480480756
• UDI-Public: 04547480480756
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: P080004
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,distri
• Initial Reporter Occupation: 505
• Type of Report: Initial,Followup
• Report Date (Section B): 06/23/2017

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: 06/30/2019
• Device Model Number: ISERT 250 (+18.50 OD)
• Device Lot Number: N/A
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 06/23/2017
• Supplement Date Received by Manufacturer: 06/23/2017
• Initial Report FDA Received Date: 07/21/2017
• Supplement 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