MAUDE Adverse Event Report: HOYA SURGICAL OPTICS, INC. HOYA - ISYMM® FC60AD; INTRAOCULAR LENS

Model Number	FC60AD (+21.00D)
Health Effect - Clinical Code	Tissue Damage (2104)
Date of Event	02/15/2016
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
The lens loaded fine, during implantation it was noticed that the trailing haptic had snapped off as the plunger of the inserter had advanced the lens.There was an enlargement of the incision when explanted.The lens was easily removed afterwards and a new iol was implanted.
Additional Manufacturer Narrative
Device evaluation details from (b)(4): one of the haptics was broken at 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: fc60-ad).
Event or Problem Description
The lens loaded fine, during implantation it was noticed that the trailing haptic had snapped off as the plunger of the inserter had advanced the lens.There was an enlargement of the incision when explanted.The lens was easily removed afterwards and a new iol was implanted.

• Brand Name: HOYA - ISYMM® FC60AD
• Common Device Name: INTRAOCULAR LENS
• Manufacturer (Section D): HOYA SURGICAL OPTICS, INC.; 14768 pipeline avenue; chino hills CA 91709
• MDR Report Key: 5471217
• Report Number: 3006723646-2016-00007
• Device Sequence Number: 272298
• Product Code: HQL
• UDI-Device Identifier: 04547480104065
• UDI-Public: 04547480104065
• Combination Product (Y/N): N
• Initial Reporter State: KS
• 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): 04/01/2016

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: 09/30/2019
• Device Model Number: FC60AD (+21.00D)
• Device Lot Number: AK835
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/23/2016
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 02/16/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 03/01/2016
• Supplement Report FDA Received Date: 04/01/2016
• 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: 82 YR