MAUDE Adverse Event Report: HOYA SURGICAL OPTICS, INC. HOYA ISERT PRELOADED IOL SYSTEM; INTRAOCULAR LENS

Model Number	HOYA 250 ISERT (+16.50 OD)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	02/21/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Hoya device has not yet been returned for evaluation.(b)(4).
Event or Problem Description
It was reported that the lens went through the patient's posterior capsule during implantation.As a result, the surgeon moved the lens to the center of the pupillary space and then cut/removed it in pieces.A vitrectomy was also performed.Because the surgeon felt the capsule would no longer support a lens, the surgery was completed by implanting a different lens into the sulcus.The patient's prognosis after surgery is excellent.
Additional Manufacturer Narrative
Device evaluation from qa (b)(4): a piece of the broken haptic from the lens was only received from the customer.The injector and the lens was not returned.Review of the production, inspection and sterilization records shows no nonconformities and/or deviations from the specification.The exact cause of this post-operative issue cannot be ascertained.(b)(4).
Event or Problem Description
It was reported that the lens went through the patient's posterior capsule during implantation.As a result, the surgeon moved the lens to the center of the pupillary space and then cut/removed it in pieces.A vitrectomy was also performed.Because the surgeon felt the capsule would no longer support a lens, the surgery was completed by implanting a different lens into the sulcus.The patient's prognosis after surgery is excellent.

• Brand Name: HOYA ISERT PRELOADED IOL SYSTEM
• 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: 6439782
• Report Number: 3006723646-2017-00006
• Device Sequence Number: 18840601
• Product Code: HQL
• UDI-Device Identifier: 04547480480718
• UDI-Public: 04547480480718
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: P080004
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/03/2017

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: Physician
• Device Expiration Date: 08/31/2019
• Device Model Number: HOYA 250 ISERT (+16.50 OD)
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/20/2017
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 03/03/2017
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 03/28/2017
• Supplement Report FDA Received Date: 06/09/2017
• 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: 65 YR