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

Model Number	ISERT 250 (+23.00 OD)
Health Effect - Clinical Codes	Failure of Implant (1924); Capsular Bag Tear (2639)
Date of Event	07/12/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Hoya device is pending evaluation.Internal reference: (b)(4).
Event or Problem Description
It was reported that during implantation of the lens in the patient's right eye, the lens dislocated and there was posterior capsule tear/rupture.The lens was removed and replaced intraoperatively with a different model iol that was placed in the sulcus.No vitrectomy was performed.The incision was not enlarged and suture was not required.According to the reporter, the likely cause of the event was "surgical technique." current patient prognosis was described as "excellent prognosis.".
Additional Manufacturer Narrative
Follow-up report #1 is being submitted to fda for the following reasons: 1.Corrections to initial report are: a) concomitant medical products: product return corrected to "no" (received empty box only - see item #2 below for more details).B) mfr site: manufacturer contact information updated for name and email of current contact person.B) report source: manufacturing site - address corrected for street address.C) date rec¿d by mfr: reporting source - added "healthcare professional" in addition to distributor.2.Additional information not available/included in initial report - findings from the manufacturer's product investigation completed on 21-sep-2017, as noted below: only the empty outer box was received on 21-aug-2017 without entire injector and lens returned.No abnormalities were found in production and inspection records of the product.Possible causes: exact root cause is not determined.From our investigation, we believe this issue is not product related.Related fields were also updated accordingly, as noted below: added check to indicate this report is follow-up #1.If follow-up, what type: added checks to indicates the report contains: correction(s) and additional information.Device evaluated by mfr: added check to "not returned to manufacturer" (received empty box only).Added event conclusion code: 92 device not returned.3.Additional information not available/included in initial report - risk analysis conducted on the product line and failure code, as noted below: a review of the most recent complaint trending data indicates no significant trends have been identified at this time, and no capa is required as part of product evaluation.This event can now be considered closed.

• 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: 6789230
• Report Number: 3006723646-2017-00020
• Device Sequence Number: 130079
• Product Code: HQL
• UDI-Device Identifier: 04547480480848
• UDI-Public: 04547480480848
• 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,health profession
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/20/2017

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: 01/31/2020
• Device Model Number: ISERT 250 (+23.00 OD)
• Device Lot Number: N/A
• Was Device Available for Evaluation?: No
• Date Returned to Manufacturer: 08/01/2017
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 07/20/2017
• Supplement Date Received by Manufacturer: 07/20/2017
• Initial Report FDA Received Date: 08/11/2017
• Supplement Report FDA Received Date: 04/25/2018
• 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
• Patient Age: 78 YR