MAUDE Adverse Event Report: ABBOTT MEDICAL OPTICS TECNIS 1-PIECE; MONOFOCAL IOLS

Model Number	ZCB00
Medical Device Problem Codes	Positioning Failure (1158); Unintended Ejection (1234)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	11/16/2016
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The lens was not implanted and therefore not explanted.All pertinent information available to abbott medical optics has been submitted.
Event or Problem Description
The lens was prematurely ejected from the cartridge during insertion into the eye.There was patient contact (no patient injury).The lens got stuck in the cartridge.No additional information was provided to abbott medical optics.
Additional Manufacturer Narrative
Additional information: it was confirmed that there was some patient contact; however, there was no vitrectomy or incision enlargement.Device available for evaluation? yes, returned to manufacturer on 1/20/2017.Device returned to manufacturer ? yes.Device evaluation: visual inspection at 10x microscope magnification was performed.Loose particles were observed on the sample which is indicative of handling the lens out of the sterile environment.A residue of viscoelastic (ovd) was detected in the optic zone.The lens was observed in its entirety.No manufacturing defects were observed in the lens optic body or in the haptics.The reported issue could not be verified.Manufacturing records review: the manufacturing records for the product were reviewed.The product was manufactured and released according to specifications.Labeling review: the directions for use (dfu) were reviewed.The dfu adequately provide instructions and precautions along with warnings for the proper use and handling of the device.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.

• Brand Name: TECNIS 1-PIECE
• Common Device Name: MONOFOCAL IOLS
• Manufacturer (Section D): ABBOTT MEDICAL OPTICS; santa ana CA
• MDR Report Key: 6214985
• Report Number: 2648035-2016-02111
• Device Sequence Number: 710384
• Product Code: HQL
• UDI-Device Identifier: 05050474531475
• UDI-Public: (01)05050474531475(17)171218
• Combination Product (Y/N): N
• Initial Reporter State: MD
• Initial Reporter Country: US
• PMA/510(K) Number: P980040
• 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
• Report Date (Section B): 02/15/2017

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: 12/18/2017
• Device Model Number: ZCB00
• Device Catalogue Number: ZCB0000080
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/20/2017
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 12/07/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 12/29/2016
• Supplement Report FDA Received Date: 02/16/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1