MAUDE Adverse Event Report: HOYA SURGICAL OPTICS, INC. HOYA ISERT 251; INTRAOCULAR LENS

Model Number	ISERT 251 (+22.00 OD)
Health Effect - Clinical Code	Tissue Damage (2104)
Date of Event	04/27/2016
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Regarding section of this report, device evaluation is pending.When investigation is completed, a follow-up report will be submitted to the fda.
Event or Problem Description
The hoya 251 tore during iol insertion, and part of the trailing haptic was still in the injector.The surgeon had to enlarge the incision to cut out the initial lens, and another hoya was implanted.Surgery was completed and patient prognosis was reported as good.
Additional Manufacturer Narrative
Complaint evaluation details from qa in (b)(6): the lens was ejected out from the injector.One of the blue pmma tips was broken from the haptic.The slider and the rod could advance properly.The rod of the injector was bent.Trace of lubricant was found inside the injector tip.No abnormalities were found in production and inspection records of the product.Root cause was not determined.(serial no.(b)(4) - model 251).
Event or Problem Description
The hoya 251 tore during iol insertion, and part of the trailing haptic was still in the injector.The surgeon had to enlarge the incision to cut out the initial lens, and another hoya was implanted.Surgery was completed and patient prognosis was reported as good.

• Brand Name: HOYA ISERT 251
• 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: 5638008
• Report Number: 3006723646-2016-00013
• Device Sequence Number: 16227722
• Product Code: HQL
• UDI-Device Identifier: 04547480450339
• UDI-Public: 04547480450339
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• Initial Reporter Country: US
• PMA/510(K) Number: P080004
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Device Explanted Year: 2016
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/27/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 10/31/2018
• Device Model Number: ISERT 251 (+22.00 OD)
• Device Lot Number: AK937
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/07/2016
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 04/27/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 05/06/2016
• Supplement Report FDA Received Date: 06/21/2016
• 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