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

Model Number	ISERT 251 (+19.00 OD)
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	03/02/2016
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Regarding 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 had to be removed after implant, widening excision and another lens placed in eye.An anterior vitrectomy was performed due to the patient's capsule failure.The doctor initially inserted a hoya 251 lens and had to remove it because the patient's capsule failed.It was replaced with a 231 lens.Patient prognosis was reported as good.
Additional Manufacturer Narrative
Device evaluation details from (b)(4): the lens was ejected out from the injector body.One of the haptics was broken at the optic/haptic junction and was not returned from the customer.The slider and the rod could advance properly.Trace of lubricant was found on the lens and inside the injector tip.No abnormalities were found in production and inspection records of the product.Root cause was not determined, and it is believed this issue is not product related.(serial no:(b)(4) - model: 251).
Event or Problem Description
Report stated that the lens had to be removed after implant, widening excision and another lens placed in eye.An anterior vitrectomy was performed due to the patient's capsule failure.The doctor initially inserted a hoya 251 lens and had to remove it because the patient's capsule failed.It was replaced with a 231 lens.Patient prognosis was reported as good.

• Brand Name: HOYA ISERT 251
• Common Device Name: INTRAOCULAR LENS
• Manufacturer (Section D): HOYA SURGICAL OPTICS, INC.; 14768 pipeline avenue; chino hills CA 91709
• MDR Report Key: 5526708
• Report Number: 3006723646-2016-00008
• Device Sequence Number: 1162232
• Product Code: HQL
• UDI-Device Identifier: 04547480450278
• UDI-Public: 04547480450278
• Combination Product (Y/N): N
• Initial Reporter State: ME
• 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?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Expiration Date: 07/31/2018
• Device Model Number: ISERT 251 (+19.00 OD)
• Device Lot Number: AK685
• 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: 03/02/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 03/25/2016
• 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: 67 YR