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)
Date of Event	03/06/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).All pertinent information available to the manufacturer has been submitted.
Event or Problem Description
It was reported that a z9002 16.5 diopter intraocular lens (iol) was explanted from a male patient's left eye due to a residual refractive outcome.The lens was explanted with no complication, no injury and no additional procedures performed.The lens was replaced with a different model with the same diopter size.The patient has recovered.No further information was provided.
Additional Manufacturer Narrative
Corrected data: in section of the initial mdr an incorrect pma/510(k) number was provided.The correct pma number for the reported device is p880081.Device available for evaluation ¿ yes, returned to manufacturer on 7/21/2017.Device returned to manufacturer ¿ yes.Device evaluation the device was returned to the manufacturer.The lens was received cut at the center with viscoelastic residues; this condition is typically of an explanted lens.The reported complaint cannot be verified due to the condition of the lens received.The customer's reported event could not be confirmed in the returned sample.Manufacturing records were reviewed and the lens was manufactured according to specification.A search on complaints revealed that no other complaint have been received for this production order 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.

• Brand Name: TECNIS CL
• Common Device Name: MONOFOCAL IOLS
• Manufacturer (Section D): ABBOTT MEDICAL OPTICS; santa ana CA
• MDR Report Key: 6681147
• Report Number: 2648035-2017-01186
• Device Sequence Number: 1539277
• Product Code: HQL
• UDI-Device Identifier: 05050474530621
• UDI-Public: (01)05050474530621(17)210711
• Combination Product (Y/N): N
• Initial Reporter State: ID
• Initial Reporter Country: US
• PMA/510(K) Number: P880081
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Device Explanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/20/2017

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: 07/11/2021
• Device Model Number: Z9002
• Device Catalogue Number: Z900200165
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/21/2017
• Initial Date Received by Manufacturer: 06/08/2017
• Supplement Date Received by Manufacturer: 07/26/2017
• Initial Report FDA Received Date: 06/30/2017
• Supplement Report FDA Received Date: 08/20/2017
• 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: 55 YR