MAUDE Adverse Event Report: HOYA SURGICAL OPTICS, INC. HOYA ISERT 231; INTRAOCULAR LENS

Model Number	ISERT 231 (+20.00D)
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	12/09/2015
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
This issue is considered mdr reportable due to patient capsule, iol needed to be removed and anterior vitrectomy performed.The surgeon did not have to enlarge the incision to remove the iol.The surgeon used a different iol once an anterior vitrectomy was performed.Patient is reported to be in stable condition.(serial no.: (b)(4) -model 231.Regarding the report, customer has indicated that they intend to return the product.Return is pending.Once received, a product investigation will be conducted.When investigation is completed, a follow-up report will be submitted to the fda.
Event or Problem Description
Due to patient capsule, iol needed to be removed and anterior vitrectomy performed.The surgeon did not have to enlarge the incision to remove the iol.Surgeon used a different iol once an anterior vitrectomy was performed.
Additional Manufacturer Narrative
The purpose of this follow-up report #1 is to provide additional information regarding device evaluation findings completed after the initial report was filed.The device evaluation was conducted by hoya qa (b)(4).Device evaluation details: upon evaluation, the lens was ejected out from the injector.The slider and the rod could advance properly.Trace of lubricant was found on the lens and inside the injector tip.A dhr (design history records) review of the manufacturing and inspection steps of this device was conducted.No abnormalities were found in production and inspection records of the product.Root cause was not determined.(b)(4).
Event or Problem Description
Due to patient capsule, iol needed to be removed and anterior vitrectomy performed.The surgeon did not have to enlarge the incision to remove the iol.Surgeon used a different iol once an anterior vitrectomy was performed.

• Brand Name: HOYA ISERT 231
• Common Device Name: INTRAOCULAR LENS
• Manufacturer (Section D): HOYA SURGICAL OPTICS, INC.; 14768 pipeline avenue; chino hills CA 91709
• MDR Report Key: 5413308
• Report Number: 3006723646-2016-00003
• Device Sequence Number: 13594515
• Product Code: HQL
• UDI-Device Identifier: 04547480351315
• UDI-Public: 04547480351315
• 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: 2015
• Device Explanted Year: 2015
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Followup
• Report Date (Section B): 01/18/2016

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: 09/30/2016
• Device Model Number: ISERT 231 (+20.00D)
• Device Lot Number: AH640
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/11/2016
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 02/05/2016
• Supplement Report FDA Received Date: 02/17/2016
• 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