MAUDE Adverse Event Report: HOYA SURGICAL OPTICS, INC. HOYA ISERT 230; INTRAOCULAR LENS

Model Number	ISERT 230 (+16.00D)
Medical Device Problem Code	Material Protrusion/Extrusion (2979)
Health Effect - Clinical Code	Device Embedded In Tissue or Plaque (3165)
Date of Event	01/27/2016
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
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
The trailing haptic had a sharp edge sticking straight out that would have cut patient's inner eye if the surgeon had left iol implanted in the eye.Patient is in good condition.No injury to the patient's eye and surgeon did not have to enlarge the incision to remove the iol.
Additional Manufacturer Narrative
The purpose of this follow-up report #1 is to provide additional information regarding device evaluation findings after the initial report was filed.The device evaluation was conducted by hoya qa singapore.Device evaluation details: only the iol was returned.One of the haptics was deformed.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: 230).
Event or Problem Description
The trailing haptic had a sharp edge sticking straight out that would have cut patient's inner eye if the surgeon had left iol implanted in the eye.Patient is in good condition.No injury to the patient's eye and surgeon did not have to enlarge the incision to remove the iol.

• Brand Name: HOYA ISERT 230
• Common Device Name: INTRAOCULAR LENS
• Manufacturer (Section D): HOYA SURGICAL OPTICS, INC.; 14768 pipeline avenue; chino hills CA 91709
• MDR Report Key: 5434607
• Report Number: 3006723646-2016-00004
• Device Sequence Number: 325671
• Product Code: HQL
• UDI-Device Identifier: 04547480301235
• UDI-Public: 04547480301235
• Combination Product (Y/N): N
• Initial Reporter State: IL
• 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): 02/01/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 08/31/2018
• Device Model Number: ISERT 230 (+16.00D)
• Device Lot Number: AK762
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/17/2016
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 02/01/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 02/12/2016
• Supplement Report FDA Received Date: 02/29/2016
• 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: 55 YR