MAUDE Adverse Event Report: ABBOTT MEDICAL OPTICS TECNIS CL; MONOFOCAL IOLS

Model Number	Z9002
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Code Available (3191)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Date of event is unknown/not provided.Exact date when patient experienced anisometropia was not provided.(b)(4).All pertinent information available to the manufacturer has been submitted.
Event or Problem Description
It was reported that a z9002 intraocular lens (iol) was removed from patient's right eye due to anisometropia.The replacement lens is unknown.There was no patient injury and no wound enlargement.No further information was provided.
Additional Manufacturer Narrative
Returned to manufacturer on 02/13/2017.The device was returned to the manufacturer.Visual inspection at 10x microscope magnification was performed and the lens was observed cut in two pieces with both lens haptics detached.Residues of what appears to be viscoelastic ovd (ophthalmic viscosurgical device) were detected in the iol , indicating the device was handled and prepared for surgical use.Based on the evidence observed, the condition of the sample is consistent with a unit that has been cut due to ¿iol removal or explant process¿ in surgery.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 requests were received for this order number to date.The directions for use (dfu) was reviewed.The dfu adequately provides instructions and precautions for the proper use and handling of the intraocular lenses.Based on the investigation results there is no indication of a product quality deficiency.All pertinent information available to the manufacturer has been submitted.
Additional Manufacturer Narrative
Corrected data: an incorrect aware date was inadvertently reported in the supplemental mdr report, follow up #1.The correct date is 02/15/2017; but was entered as 12/15/2016 in date received by mfr of the supplemental mdr report.All pertinent information available to the manufacturer has been submitted.

• Brand Name: TECNIS CL
• Common Device Name: MONOFOCAL IOLS
• Manufacturer (Section D): ABBOTT MEDICAL OPTICS; santa ana CA
• MDR Report Key: 6214750
• Report Number: 2648035-2016-02108
• Device Sequence Number: 18878244
• Product Code: HQL
• UDI-Device Identifier: 05050474530638
• UDI-Public: (01)05050474530638(17)181108
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• Initial Reporter Country: US
• PMA/510(K) Number: P880081
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2014
• Device Explanted Year: 2016
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 04/10/2017

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: 11/08/2018
• Device Model Number: Z9002
• Device Catalogue Number: Z900200170
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/13/2017
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 12/07/2016
• Supplement Date Received by Manufacturer: Not provided; Not provided
• Initial Report FDA Received Date: 12/29/2016
• Supplement Report FDA Received Date: 03/15/2017; 04/10/2017
• 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