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

Model Number	HOYA ISYMM FC-60AD (+21.00 OD)
Health Effect - Clinical Code	Tissue Damage (2104)
Date of Event	04/12/2016
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device evaluation is pending.When investigation is completed, a follow-up report will be submitted to the fda.
Event or Problem Description
Report stated that the surgeon had to enlarge the incision to explant the iol from the patient's eye.Another hoya iol was implanted and no scheduling of an additional surgery was required.The patient's prognosis is unknown at this time as no additional information was made available.Customer reports the malfunction as a deformed haptic.
Additional Manufacturer Narrative
Complaint evaluation details from qa (b)(6) - the lens was returned with the lens case.One of the haptics was deformed and broken at the root of the optic/haptic junction.Trace of lubricant was found on the lens.No abnormalities were found in production and inspection records of the product.Root cause was not determined.(serial no.(b)(4) - model- fc-60ad).
Event or Problem Description
Report stated that the surgeon had to enlarge the incision to explant the iol from the patient's eye.Another hoya iol was implanted and no scheduling of an additional surgery was required.The patient's prognosis is unknown at this time as no additional information was made available.Customer reports the malfunction as a deformed haptic.

• Brand Name: HOYA ISYMM FC-60AD
• Common Device Name: INTRAOCULAR LENS
• Manufacturer (Section D): HOYA SURGICAL OPTICS, INC.; 14768 pipeline avenue; chino hills CA 91709
• MDR Report Key: 5591740
• Report Number: 3006723646-2016-00012
• Device Sequence Number: 10768370
• Product Code: HQL
• UDI-Device Identifier: 04547480104065
• UDI-Public: 04547480104065
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/18/2016

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: 05/31/2017
• Device Model Number: HOYA ISYMM FC-60AD (+21.00 OD)
• Device Lot Number: AH355
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/17/2016
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 04/13/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 04/20/2016
• Supplement Report FDA Received Date: 05/18/2016
• 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
• Patient Age: 68 YR