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

Model Number	ZCB00
Medical Device Problem Code	Material Discolored (1170)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	09/14/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Age/date of birth: unknown, information not provided.Gender/sex: unknown, information not provided.If implanted, give date: not applicable, as the lens was not implanted.If explanted, give date: not applicable, as the lens was not implanted.(b)(6).All pertinent information available to abbott medical optics has been submitted.
Event or Problem Description
It was reported that when a zcb00 9.5 diopter intraocular lens (iol) holder was opened to set the lens into the cartridge for implantation, the surgeon noticed a gray zone, perhaps cloudy, either on or inside the center of the lens.Reportedly, the lens was not implanted and the patient was no affected.Another lens was used and implanted successfully.No additional information was provided.
Additional Manufacturer Narrative
Device available for evaluation, returned to manufacturer on: 12/19/2017.Device evaluation: the intraocular lens (iol) was returned at the manufacturing site for evaluation.Visual inspection showed particles on the lens appearing to come from the environment.In addition, there was a stain (white) near the lens edge.The stain was observed over the lens not embedded.The complaint reported was confirmed.However, as the lens was handled, the source of the stain could not be determined.Manufacturing records review: the manufacturing records for the intraocular lens were reviewed.During manufacturing the lenses are 100% cleaned and inspected at 10x microscope magnification.The product was manufactured and released according to specification.Labeling review: the directions for use (dfu) adequately provides instructions and precautions along with warnings for the proper use and handling of the device.The dfu states to examine the lens thoroughly to ensure particles have not become attached to it, and examine the lens optical surfaces for other defects.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 92705
• MDR Report Key: 6946905
• Report Number: 2648035-2017-01864
• Device Sequence Number: 19085567
• Product Code: HQL
• UDI-Device Identifier: 05050474531505
• UDI-Public: (01)05050474531505(17)180116
• Combination Product (Y/N): N
• Initial Reporter Country: FI
• PMA/510(K) Number: P980040
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 02/05/2018

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: 01/16/2018
• Device Model Number: ZCB00
• Device Catalogue Number: ZCB0000095
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/19/2017
• Initial Date Received by Manufacturer: 09/18/2017
• Supplement Date Received by Manufacturer: 01/10/2018
• Initial Report FDA Received Date: 10/12/2017
• Supplement Report FDA Received Date: 02/05/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1