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

Model Number	ZA9003
Medical Device Problem Code	Device Contamination with Chemical or Other Material (2944)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	12/20/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The intraocular lens was not implanted.All pertinent information available to abbott medical optics has been submitted.
Event or Problem Description
It was reported that the lens was contaminated during handling/prior to insertion.There was no patient contact.No additional information was provided to abbott medical optics.
Additional Manufacturer Narrative
Device available for evaluation, returned to manufacturer on: 02/20/2018.Device evaluation: the lens was returned to the manufacturer.Visual inspection at 10x microscope magnification was performed.Only loose fibers/particles were observed on lens and may be related to product handling in a non-sterile environment.No damage or defect was observed on the lens or lens haptic.There was no additional information provided in regards to lens contamination due to handling.The reported complaint was verified, but based on product evaluation it was not possible to determine if it was related to manufacturing process as the returned lens was handled during surgical procedure.Manufacturing record review: manufacturing record review of the production order and related document revealed that the product was manufactured and released according to specification.There was no discrepancy found during the review.A search revealed that no additional complaints were received for this production order.Sterilization records: the sterilization record was reviewed and no deviations were found that affected the sterility of the device.Labeling review: the directions for use (dfu) was reviewed.The dfu adequately provides instructions and precautions for the proper use and handling of the product.Conclusion: based on the investigation results, there is no indication of a product quality deficiency.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.

• Brand Name: TECNIS
• Common Device Name: MONOFOCAL IOLS
• Manufacturer (Section D): ABBOTT MEDICAL OPTICS; santa ana CA
• MDR Report Key: 7261418
• Report Number: 2648035-2018-00222
• Device Sequence Number: 987267
• Product Code: HQL
• UDI-Device Identifier: 05050474528888
• UDI-Public: (01)05050474528888(17)220912
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: P990080
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,health profession
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/02/2018

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: 09/12/2022
• Device Model Number: ZA9003
• Device Catalogue Number: ZA90030135
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/20/2018
• Initial Date Received by Manufacturer: 01/12/2018
• Supplement Date Received by Manufacturer: 03/05/2018
• Initial Report FDA Received Date: 02/09/2018
• Supplement Report FDA Received Date: 04/02/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1