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

Model Number	ISERT 230 (+15.00D)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	02/02/2016
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product evaluation stated that the complaint product was not returned.Complaint investigation was unable to perform a visual inspection on the product as the complaint product was not returned from customer.According to the information from the customer, the leading haptic broke off during insertion.No abnormalities were found in production and inspection records of the product.Root cause was not determined.(serial no.: (b)(4)-model 230.Internal reference: (b)(4).
Event or Problem Description
During iol insertion, the leading haptic broke off while plunging forward.The incision needed to be enlarged to remove the iol.No injury and the patient is reported to be in stable condition.The facility disposed of the product and was unable to return it for proper investigation.

• 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: 5448488
• Report Number: 3006723646-2016-00006
• Device Sequence Number: 402098
• Product Code: HQL
• UDI-Device Identifier: 04547480301310
• UDI-Public: 04547480301310
• Combination Product (Y/N): N
• Initial Reporter State: MO
• 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
• Report Date (Section B): 02/02/2016

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: 05/31/2017
• Device Model Number: ISERT 230 (+15.00D)
• Device Lot Number: AJ483
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/02/2016
• Initial Report FDA Received Date: 02/19/2016
• 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: 63 YR