MAUDE Adverse Event Report: HOYA SURGICAL OPTICS, INC. HOYA ISERT 251; INTRAOCULAR LENS

Model Number	HOYA ISERT 251 (+23.00 OD)
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	08/31/2016
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.(b)(4).
Event or Problem Description
Report stated that the surgeon had to enlarge the incision to 2.5mm for removal of lens.This event occured right after iol implantation.The patient's prognosis was reported as "recovered." customer reports the malfunction as a "cracked haptic.".
Additional Manufacturer Narrative
The product was not returned, visual inspection was not performed and further information could not be provided.No abnormalities were found in production and inspection records of the product.The exact root cause was not ascertained.(b)(4).
Event or Problem Description
Report stated that the surgeon had to enlarge the incision to 2.5mm for removal of lens.This event occured right after iol implantation.The patient's prognosis was reported as "recovered." customer reports the malfunction as a "cracked haptic.".

• Brand Name: HOYA ISERT 251
• 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: 5943587
• Report Number: 3006723646-2016-00019
• Device Sequence Number: 748187
• Product Code: HQL
• UDI-Device Identifier: 04547480450353
• UDI-Public: 04547480450353
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• 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): 09/01/2016

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: 10/31/2018
• Device Model Number: HOYA ISERT 251 (+23.00 OD)
• Was Device Available for Evaluation?: No
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 09/07/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 09/12/2016
• Supplement Report FDA Received Date: 10/21/2016
• 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