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

Model Number	ISERT 230 (+19.00 OD)
Health Effect - Clinical Code	Eye Injury (1845)
Date of Event	01/18/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Hoya device is pending evaluation.(b)(4).
Event or Problem Description
Reportedly, a tear in the iol was noticed after iol insertion into the right eye.The lens was removed and replaced with the backup lnes of the same model and the same diopter.The incision was enlarged to remove the lens.Sutures were placed as a part of standard prcedure.Patient prognosis and outcome are good.
Additional Manufacturer Narrative
Follow-up report #1 is being submitted to fda for the following reasons: corrected information not available/reporting in initial report: manufacturer contact information updated to current contact name and email.Corrected manufacturing site street address added "healthcare professional" in addition to "distributor." related fields were also updated accordingly, as noted below: added check to indicate this report is follow-up #1.Section added checks to indicates the report contains: corrections and additional information.Changed to "yes." added evaluation results code: 114.Additional information not available/included in initial report - findings from the manufacturer's product investigation completed on 09-apr-2018, as noted below: complaint product was returned from the customer.Product investigation was performed.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.Additional information not available/included in the 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 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: 7293490
• Report Number: 3006723646-2018-00008
• Device Sequence Number: 1354929
• Product Code: HQL
• UDI-Device Identifier: 04547480301297
• UDI-Public: 04547480301297
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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): 02/06/2018

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: 11/30/2019
• Device Model Number: ISERT 230 (+19.00 OD)
• Device Lot Number: N/A
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 03/06/2018
• Supplement Date Received by Manufacturer: 03/06/2018
• Initial Report FDA Received Date: 02/23/2018
• Supplement Report FDA Received Date: 04/30/2018
• 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: 79 YR