MAUDE Adverse Event Report: HOYA SURGICAL OPTICS, INC. HOYA ISERT 250; INTRAOCULAR LENS

Model Number	HOYA 250 ISERT (+30.00 OD)
Health Effect - Clinical Code	Tissue Damage (2104)
Date of Event	02/03/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Regarding device evaluated by mfr?, hoya device has not yet been returned.(b)(4).
Event or Problem Description
The lens sn: (b)(4) was implanted first and needed to be cut in half and removed from the eye.The patient was not adversely affected and sutures were not required, but the incision was enlarged to facilitate removal.The surgeon then attempted to implant the second lens (b)(4); and this one also had difficulties.A different model lens was implanted.Additional information has been requested but has not yet been received.
Additional Manufacturer Narrative
Device evaluation from qa (b)(4): the lens was ejected out from the injector tip and was not returned, therefore visual inspection could not be performed on the lens.The slider and the screw could advance fully.Trace of lubricant was found inside the injector tip.Sn:(b)(4).
Event or Problem Description
The lens sn: (b)(4) was implanted first and needed to be cut in half and removed from the eye.The patient was not adversely affected and sutures were not required, but the incision was enlarged to facilitate removal.The surgeon then attempted to implant the second lens (b)(4); and this one also had difficulties.A different model lens was implanted.Additional information has been requested but has not yet been received.

• Brand Name: HOYA ISERT 250
• 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: 6413681
• Report Number: 3006723646-2017-00004
• Device Sequence Number: 19063854
• Product Code: HQL
• UDI-Device Identifier: 04547480480985
• UDI-Public: 04547480480985
• Combination Product (Y/N): N
• Initial Reporter State: MD
• 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): 03/17/2017

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: Health Professional
• Device Expiration Date: 05/31/2019
• Device Model Number: HOYA 250 ISERT (+30.00 OD)
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/17/2017
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 02/14/2017
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 03/17/2017
• Supplement Report FDA Received Date: 04/03/2017
• 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