MAUDE Adverse Event Report: ABBOTT MEDICAL OPTICS TECNIS 1-PIECE; MONOFOCAL IOLS

Model Number	ZCB00
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Vitreous Loss (2142); Capsular Bag Tear (2639); Vitrectomy (2643)
Date of Event	06/06/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Implant and explant dates: if implanted or explanted, give date: not applicable as the lens was inserted and removed.(b)(4).Device evaluation the device was not returned to the manufacturer for evaluation.Device inspection could not be performed.The reported issue could not be verified.Manufacturing records were reviewed and the lens was manufactured according to specification.A search on complaints revealed no additional investigation request for this production order (po) number.The directions for use (dfu) was reviewed.The dfu adequately provides instructions and precautions for the proper use and handling of the device.Based on the investigation results there is no indication of a product quality deficiency.All pertinent information available to the manufacturer has been submitted.
Event or Problem Description
It was initially reported that the physician had to perform a vitrectomy and replace the zcb00 17.0 diopter intraocular lens (iol) as there was a leak (vitreous leak) with the patient's eye.The zcb00 lens was replaced with a 3-piece lens.Through follow up clarification was provided.When the lens was inserted into the eye the physician noticed that there was a tear in the capsular bag.The physician was unsure if the tear was due to the iol or patient anatomy.An incision enlargement was required to remove the zcb00 iol, a vitrectomy was conducted and the lens was replaced with a back-up iol.There was no post-op patient injury.It was noted the device was discarded.No other information was provided.

• Brand Name: TECNIS 1-PIECE
• Common Device Name: MONOFOCAL IOLS
• Manufacturer (Section D): ABBOTT MEDICAL OPTICS; santa ana CA
• MDR Report Key: 6679910
• Report Number: 2648035-2017-01185
• Device Sequence Number: 13499716
• Product Code: HQL
• UDI-Device Identifier: 05050474531659
• UDI-Public: (01)05050474531659(17)180710
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: P980040
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 06/29/2017

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: Physician
• Device Expiration Date: 07/10/2018
• Device Model Number: ZCB00
• Device Catalogue Number: ZCB0000170
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/07/2017
• Initial Report FDA Received Date: 06/30/2017
• 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: Required Intervention
• Patient Age: 74 YR