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

Model Number	HOYA ISYMM FY-60AD (+13.00 OD)
Health Effect - Clinical Code	Complaint, Ill-Defined (2331)
Date of Event	10/20/2016
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Date of event was not provided at this time.Regarding section h3 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
Report stated that the lens was removed due to a broken capsule, and an enlargement of the incision was also reported.Patient outcome was reported as "still under treatment.".
Additional Manufacturer Narrative
Date of event was (b)(6) 2016.In the surgeon's opinion the likely cause of this event was patient's pre-existing condition of poor zonules and not a product malfunction.Ref: (b)(4).
Event or Problem Description
Report stated that the lens was removed due to a broken capsule, and an enlargement of the incision was also reported.Patient outcome was reported as "still under treatment.".

• Brand Name: HOYA ISYMM FY-60AD
• 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: 6074149
• Report Number: 3006723646-2016-00021
• Device Sequence Number: 18954568
• Product Code: HQL
• UDI-Device Identifier: 04547480202983
• UDI-Public: 04547480202983
• Combination Product (Y/N): N
• Initial Reporter State: PA
• 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: distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 11/09/2016

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 01/31/2020
• Device Model Number: HOYA ISYMM FY-60AD (+13.00 OD)
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 10/24/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 11/02/2016
• Supplement Report FDA Received Date: 11/09/2016
• 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: 65 YR