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

Model Number	ISERT 250 (+19.50 OD)
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Capsular Bag Tear (2639); No Code Available (3191)
Date of Event	07/17/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Complaint evaluation details from qa (b)(4): only the emply outer box was returned without the injector and lens.(b)(4).
Event or Problem Description
It was reported that the surgeon ruptured the posterior capsule during lens manipulation in the left eye.Lens had to be removed and replaced with another model lens.Vitrectomy was performed.
Additional Manufacturer Narrative
Follow-up report #1 is being submitted to fda for the following reasons: corrected information - from information provided on the initial report section g1,2 - changed name of contact person to the current contact person and corrected spelling of manufacturing address in singapore.Additional information - not available/included in the initial report - manufacturer's codes: section h6 - added manufacturer's codes for: patient, device, method, results, and conclusion.Note: initial submission of this follow-up #1 - was returned from esg as "failed" therefore, this report was updated - to revised codes for method and conclusion.Additional information - not available/included in the initial report - manufacturer's product/complaint investigation is noted below.Since only the outer box was returned, without the lens or injector, product investigation could not be performed.No abnormalities were found in a review of the production and inspection records.From the 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 codes, as noted below: a review of the most recent complaint trending data for this complaint indicates no significant trends identified at the time, and no capa required as part of the 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: 6887425
• Report Number: 3006723646-2017-00023
• Device Sequence Number: 820191
• Product Code: HQL
• UDI-Device Identifier: 04547480480770
• UDI-Public: 04547480480770
• Combination Product (Y/N): N
• Initial Reporter State: IL
• 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): 07/24/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 12/31/2019
• Device Model Number: ISERT 250 (+19.50 OD)
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/21/2017
• 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: 09/22/2017
• Supplement Report FDA Received Date: 07/13/2018
• 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: 83 YR