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

Model Number	Z9002
Medical Device Problem Codes	Break (1069); Device Damaged Prior to Use (2284); Scratched Material (3020)
Health Effect - Clinical Code	No Patient Involvement (2645)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
If explanted, give date: not applicable as the device was not used.Device evaluation the device was returned to the manufacturer.The unit was received in a re-sealable plastic bag and the lens case insert assembly was returned as well.Visual inspection at 10x microscope magnification was performed and the lens was received with scratches.One haptic was observed detached the and other distorted.There are no viscoelastics observed on the lens.The reported device problem was verified.Manufacturing records were reviewed and the lens was manufactured according to specification.A search on complaints revealed no additional complaints 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.
Event or Problem Description
It was reported that the z9002 18.0 diopter intraocular lens (iol) was defective out of the box.There was no patient contact.No other information was provided.

• Brand Name: TECNIS CL
• Common Device Name: MONOFOCAL IOLS
• Manufacturer (Section D): ABBOTT MEDICAL OPTICS; santa ana CA
• MDR Report Key: 6371105
• Report Number: 2648035-2017-00388
• Device Sequence Number: 1081591
• Product Code: HQL
• UDI-Device Identifier: 05050474530652
• UDI-Public: (01)05050474530652(17)190703
• Combination Product (Y/N): N
• Initial Reporter State: CT
• 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
• Report Date (Section B): 03/01/2017

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: 07/03/2019
• Device Model Number: Z9002
• Device Catalogue Number: Z900200180
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/01/2017
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/02/2017
• Initial Report FDA Received Date: 03/02/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1