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

Model Number	HOYA 250 ISERT (+24.00 OD)
Health Effect - Clinical Code	Injury (2348)
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 while doctor was advancing the lens, it stuck in the injector.The injector/lens was removed and the incision was enlarged.A back-up lens was implanted with no issue.Patient's outcome is good.
Additional Manufacturer Narrative
Device evaluation from qa (b)(4): sn: (b)(4): the lens was ejected from the injector tip and was not returned.The slider and the screw could advance fully.Trace of lubricant was found inside the injector tip.Internal reference: (b)(4).
Event or Problem Description
It was reported while doctor was advancing the lens, it stuck in the injector.The injector/lens was removed and the incision was enlarged.A back-up lens was implanted with no issue.Patient's outcome is good.

• 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: 6424840
• Report Number: 3006723646-2017-00005
• Device Sequence Number: 602680
• Product Code: HQL
• UDI-Device Identifier: 04547480480862
• UDI-Public: 04547480480862
• 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
• Reporter Type: Manufacturer
• Report Source: distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/21/2017

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 (+24.00 OD)
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 02/24/2017
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 03/22/2017
• Supplement Report FDA Received Date: 03/27/2017
• 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