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

Model Number	Z9002
Medical Device Problem Code	Torn Material (3024)
Health Effect - Clinical Codes	No Patient Involvement (2645); No Information (3190)
Date of Event	10/12/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
All pertinent information available to abbott medical optics has been submitted.
Event or Problem Description
It was reported that the intraocular lens was sheared.No additional information was provided to abbott medical optics.
Additional Manufacturer Narrative
Device evaluation: the product was not returned for investigation.The reported issue was not verified.Manufacturing records review: the manufacturing records for the product were reviewed.The product was manufactured and released according to specifications.A search revealed that no additional complaints for this order number have been received.Labeling review: the directions for use (dfu) were reviewed.The dfu provide the customer with proper usage instructions and guidelines.Conclusion: as a result of the investigation, there is no indication of a product quality deficiency.All pertinent information available to abbott medical optics has been submitted.
Additional Manufacturer Narrative
Additional information: during follow up, the customer stated there was no patient contact.It was confirmed that the issue was lens sheared.The following section has been updated accordingly: (b)(4).All pertinent information available to abbott medical optics has been submitted.

• Brand Name: TECNIS CL
• Common Device Name: MONOFOCAL IOLS
• Manufacturer (Section D): ABBOTT MEDICAL OPTICS; santa ana CA
• MDR Report Key: 7021779
• Report Number: 2648035-2017-02035
• Device Sequence Number: 11111115
• Product Code: HQL
• UDI-Device Identifier: 05050474530645
• UDI-Public: (01)05050474530645(17)220220
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: P880081
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 02/21/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Physician
• Device Expiration Date: 02/20/2022
• Device Model Number: Z9002
• Device Catalogue Number: Z900200175
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 10/13/2017
• Supplement Date Received by Manufacturer: 11/28/2017; 01/24/2018
• Initial Report FDA Received Date: 11/10/2017
• Supplement Report FDA Received Date: 12/26/2017; 02/21/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1