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

Model Number	ISERT 250 (+24.50 OD)
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	04/04/2017
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 capsule tore while the surgeon implanted a hoya lens.The surgeon had to remove the hoya lens, performed vitrectomy, and then proceeded to implant a sofport lens.It is unknown why the sofport lens was also pulled out.The surgeon performed vitrectomy again and ended up implanting a different brand lens.Additional information has been requested but has not been received.
Additional Manufacturer Narrative
Regarding section this report, hoya device has not yet been returned for evaluation.Correction: changed to (b)(4).(b)(4).
Event or Problem Description
It was reported that capsule tore while the surgeon implanted a hoya lens.The surgeon had to remove the hoya lens, performed vitrectomy, and then proceeded to implant a sofport lens.It is unknown why the sofport lens was also pulled out.The surgeon performed vitrectomy again and ended up implanting a different brand lens.Additional information has been requested but has not been received.
Additional Manufacturer Narrative
Complaint evaluation details from (b)(4): the lens was ejected out from the injector tip and was not returned.The slider and the rod could advance fully.The cartridge tip was deformed.Trace of lubricant was found inside the injector tip.Review of the production, inspection and sterilization records shows no non-conformities and/or deviation from the specification.(b)(4).
Event or Problem Description
It was reported that capsule tore while the surgeon implanted a hoya lens.The surgeon had to remove the hoya lens, performed vitrectomy, and then proceeded to implant a sofport lens.It is unknown why the sofport lens was also pulled out.The surgeon performed vitrectomy again and ended up implanting a different brand lens.Additional information has been requested but has not 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: 6552891
• Report Number: 3006723646-2017-00010
• Device Sequence Number: 1279331
• Product Code: HQL
• UDI-Device Identifier: 04547480480879
• UDI-Public: 04547480480879
• 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: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 06/05/2017

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: 06/30/2019
• Device Model Number: ISERT 250 (+24.50 OD)
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/17/2017
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 04/14/2017
• Supplement Date Received by Manufacturer: Not provided; Not provided
• Initial Report FDA Received Date: 05/08/2017
• Supplement Report FDA Received Date: 05/12/2017; 06/05/2017
• 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: Other