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

Model Number	ZA9003
Medical Device Problem Codes	Material Discolored (1170); Material Opacification (1426); Device Contamination with Chemical or Other Material (2944)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	11/30/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
If implanted, give date: not applicable, as lens was inserted, removed and replaced.If explanted, give date: not applicable, as lens was inserted, removed and replaced.All pertinent information available to abbott medical optics has been submitted.
Event or Problem Description
It was initially reported that a model za9003 lens was inserted and removed from the eye.In further communication, it was learned that following uneventful removal of a cataract, a model za9003 17.5 diopter lens was inserted into the eye.Once the lens was well-seated and centered, it was noted that a flaw, or blemish was present in the lens.This appeared to be some type of stain, or cloudy film embedded in the lens.Since it was directly in the visual field, the lens was removed and replaced.The lens was divided and removed through the incision, and another za9003 17.5 diopter lens was implanted.No widening of the incision or suture was necessary to close the wound.There were no problems or issues noted on the next day¿s post-op visit.No further information was provided.
Additional Manufacturer Narrative
Additional information: device available for evaluation, returned to manufacturer on 1/18/2018.Device evaluation: the intraocular lens (iol) was returned to the manufacturing site for evaluation.Lens was returned cut in two pieces.Loose fibers/particles were observed on lens pieces related to the handling of the unit out of a sterile environment.Residues of lubricant material were also observed on lens pieces which indicate the unit was handled and prepare for surgical use.Both haptics was observed damaged/distorted.Some yellow stains were also observed on lens pieces.Based on the evidence observed, it was difficult to distinguish any stains and cloudy film embedded due to the dried salt solution and presumably other body fluids on this lens.However, lens was sent an outside lab for further analysis to identify the foreign material observed on lens.Edx analysis shows that the stains are consistent with salts and biological material.Lens was evaluated with sme (subject matter expert) to address the complaint issue reported.Potential and indirect exposure to that type of material is not possible, since throughout the manufacturing processes there are various cleaning operations and 100% visual inspection utilizing a microscope magnification steps that would have identified and discarded a lens with a similar particulate or substance, as required by our approved procedures.The manufacturing controls should be capable to identify the presence of this type of particulate or substance during the inspection controls defined as part of the manufacturing process.In addition, as required in the direction for use (dfu) the lens should be removed from the pouch in a sterile environment, and examined thoroughly to ensure particles have not been attached before implanting.However, based on the evidence observed, the particle or substance observed is not related to manufacturing.The complaint issue reported was not verified.Manufacturing records review: the manufacturing records for the intraocular lens were reviewed.The product was manufactured and released according to specification.A search on complaints revealed that no additional investigations requested for this production order number.Labeling review: the directions for use (dfu) was reviewed.The dfu adequately provides instructions and precautions along with warnings for the proper use and handling of the device.As a result of the investigation, there is no indication of a product quality deficiency and the reported issue could not be verified.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: 7153473
• Report Number: 2648035-2017-02386
• Device Sequence Number: 13666596
• Product Code: HQL
• UDI-Device Identifier: 05050474528963
• UDI-Public: (01)05050474528963(17)220718
• Combination Product (Y/N): N
• Initial Reporter State: MO
• Initial Reporter Country: US
• PMA/510(K) Number: P990080
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/15/2018

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: 07/18/2022
• Device Model Number: ZA9003
• Device Catalogue Number: ZA90030175
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/18/2018
• Initial Date Received by Manufacturer: 11/30/2017
• Supplement Date Received by Manufacturer: 02/16/2018
• Initial Report FDA Received Date: 12/28/2017
• Supplement Report FDA Received Date: 03/16/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1