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

Model Number	HOYA ISYMM FY-60AD (+22.50 OD)
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	06/21/2016
Type of Reportable Event	Serious Injury
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
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 the patient's prognosis was reported as good on day of event ((b)(6) 2016).On the post event follow-up visit - ((b)(6) 2016), the doctor reported patient's condition worsened.Customer reports the malfunction as a "cracked or deformed cartridge tip splitting and lens cracking during iol insertion.
Additional Manufacturer Narrative
Complaint evaluation details from qa (b)(4) - the iol and lens case was only received from the customer.As the injector was not returned, visual inspection was not performed and further information could not be provided.One of the haptics was broken and was not returned.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-fy-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 the patient's prognosis was reported as good on day of event ((b)(6) 2016).On the post event follow-up visit - ((b)(6) 2016), the doctor reported patient's condition worsened.Customer reports the malfunction as a "cracked or deformed cartridge tip splitting and lens cracking during iol insertion.

• 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: 5843441
• Report Number: 3006723646-2016-00018
• Device Sequence Number: 446182
• Product Code: HQL
• UDI-Device Identifier: 04547480203171
• UDI-Public: 04547480203171
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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): 06/21/2016

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: 02/29/2020
• Device Model Number: HOYA ISYMM FY-60AD (+22.50 OD)
• Device Lot Number: AL168
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 06/21/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 08/03/2016
• Supplement Report FDA Received Date: 08/15/2016
• 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: 73 YR