MAUDE Adverse Event Report: HOYA SURGICAL OPTICS, INC. HOYA ISERT 251; INTRAOCULAR LENS

Model Number	ISERT 251 (+19.50 OD)
Health Effect - Clinical Code	Visual Impairment (2138)
Date of Event	09/04/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This information was sent to the investigation laboratory for further investigation.Pending return of the device.Reference number: (b)(4).
Event or Problem Description
It was reported lens substitution due to opacification of the iol with visual acuity reduction.This occurred from 2011 to 2017.Patient impact is unknown at this time.
Additional Manufacturer Narrative
Follow-up report #1 is being submitted to fda for the following reasons: corrections to initial report are: section d10 - device available - changed to "no".Section g 1 - manufacturer contact information updated for name and email of current contact person.Section g 2 - manufacturing site - address updated to current location.Additional information not available/included in initial report - findings from the manufacturer's product investigation completed on 19-mar-2018, as noted below: per updated information as of 13-mar-2018, complaint product will not be returned back form the customer.As the product was not retuned, visual inspection could not be performed and further information could not be provided about the lens and the entire injector.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: section g7 - added check to indicate this report is follow-up #1.Section h2 - added checks to indicates the report contains: correction(s) and additional information.Section h3 - added check to "not returned to manufacturer".Section h6 - added event conclusion code: 92 device not returned.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 251
• 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: 7076430
• Report Number: 3006723646-2017-00029
• Device Sequence Number: 1272533
• Product Code: HQL
• UDI-Device Identifier: 04547480450285
• UDI-Public: 04547480450285
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• PMA/510(K) Number: P080004
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: foreign,other
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 10/30/2017

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 01/01/2013
• Device Model Number: ISERT 251 (+19.50 OD)
• Device Lot Number: N/A
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 10/30/2017
• Supplement Date Received by Manufacturer: 10/30/2017
• Initial Report FDA Received Date: 12/01/2017
• Supplement Report FDA Received Date: 04/26/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1