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

Model Number	Z9002
Medical Device Problem Code	Scratched Material (3020)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	10/16/2017
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 inserted and removed.If explanted, give date: not applicable, as the lens was inserted and removed.All pertinent information available to abbott medical optics has been submitted.
Event or Problem Description
It was reported that a z9002 18.5 diopter intraocular lens (iol) was noticed scratched after being inserted into the patient's operative eye during the same surgery.The procedure was completed successfully using a backup lens with same model and diopter size.There was no vitrectomy performed and no serious patient injury reported.No additional information was provided.
Additional Manufacturer Narrative
Device evaluation: the product testing was not performed as the complaint device was not returned for analysis.The reported complaint cannot be confirmed.Manufacturing record review: manufacturing records were reviewed.The units were manufactured and released according to specifications.A review of complaints revealed that no other complaints have been opened under this production order.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 the manufacturer has been submitted.
Additional Manufacturer Narrative
Device available for evaluation, returned to manufacturer on: 03/07/2018.Device evaluation: the sample was returned to the manufacturer.Visual inspection at 10x microscope magnification was performed on returned lens.Loose fibers/particles were observed and may be related to product handling in a non-sterile environment.Residues of lubricant material were also observed, indicating that the unit was handled and prepared for surgical use.One of the haptic was observed damaged/distorted.No damaged was observed to the other haptic.No scratches were also observed on lens.The complaint issue reported was not verified.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.

• Brand Name: TECNIS CL
• Common Device Name: MONOFOCAL IOLS
• Manufacturer (Section D): ABBOTT MEDICAL OPTICS; santa ana CA
• MDR Report Key: 7026299
• Report Number: 2648035-2017-02067
• Device Sequence Number: 1975215
• Product Code: HQL
• UDI-Device Identifier: 05050474530669
• UDI-Public: (01)05050474530669(17)210819
• Combination Product (Y/N): N
• Initial Reporter State: KS
• 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,Followup,Followup
• Report Date (Section B): 04/05/2018

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: 08/19/2021
• Device Model Number: Z9002
• Device Catalogue Number: Z900200185
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/07/2018
• Initial Date Received by Manufacturer: 10/16/2017
• Supplement Date Received by Manufacturer: 12/07/2017; 03/08/2018
• Initial Report FDA Received Date: 11/13/2017
• Supplement Report FDA Received Date: 01/05/2018; 04/05/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1