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

Model Number	ISERT® 250 (+21.00D)
Medical Device Problem Code	Sticking (1597)
Health Effect - Clinical Code	Corneal Edema (1791)
Date of Event	02/03/2016
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Regarding the report, device evaluation is pending.When investigation is completed, a follow-up report will be submitted to the fda.
Event or Problem Description
It was reported that an incident occurred with the hoya isertodel 250 lens, in which the pmma tip was embeded into the optic, noted after iol implant.Several different attempts to unfold the haptic were performed by the surgeon.The surgeon cut out the lens into several pieces for separation of haptic from the patient's eye.According to surgeon, patient prognosis is reported as doing fine, with some expected corneal edema.
Additional Manufacturer Narrative
The purpose of this follow-up report #1 is to provide additional information regarding device evaluation findings after the initial report was filed.The device evaluation was conducted by hoya (b)(4).Device evaluation details: the lens was ejected out from the injector tip.One of the haptics was broken at the root of the optic/haptic junction.The pmma tip from the broken haptic was embedded into the optic.The slider and the rod could advance.Trace of lubricant was found on the lens and inside the injector tip.No abnormalities were found in production and inspection records of the product.(serial no: (b)(4), model: 250).
Event or Problem Description
It was reported that an incident occurred with the hoya isert® model 250 lens, in which the pmma tip was embedded into the optic, noted after iol implant.Several different attempts to unfold the haptic were performed by the surgeon.The surgeon cut out the lens into several pieces for separation of haptic from the patient's eye.According to surgeon, patient prognosis is reported as doing fine, with some expected corneal edema.

• Brand Name: HOYA ISERT® 250
• Common Device Name: INTRAOCULAR LENS
• Manufacturer (Section D): HOYA SURGICAL OPTICS, INC.; 14768 pipeline avenue; chino hills CA 91709
• MDR Report Key: 5459106
• Report Number: 3006723646-2016-00005
• Device Sequence Number: 13528416
• Product Code: HQL
• UDI-Device Identifier: 04547480480800
• UDI-Public: 04547480480800
• 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: 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): 02/12/2016

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 11/30/2018
• Device Model Number: ISERT® 250 (+21.00D)
• Device Lot Number: AKA51
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/17/2016
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 02/03/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 02/24/2016
• Supplement Report FDA Received Date: 02/29/2016
• 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