MAUDE Adverse Event Report: JOHNSON AND JOHNSON SURGICAL VISION, INC. TECNIS CL; MONOFOCAL IOLS

Model Number	Z9002
Medical Device Problem Code	Scratched Material (3020)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	03/07/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
If implanted; give date: n/a (not applicable).The intraocular lens was removed and replaced during the same procedure.If explanted; give date: n/a (not applicable).The intraocular lens was removed and replaced during the same procedure.All pertinent information available to johnson and johnson surgical vision, inc.Has been submitted.
Event or Problem Description
It was noted that there was a scratch on the center of the lens when inserting it into the eye.The lens was fully inserted.There was no incision enlargement, no serious patient injury, no sutures and no vitrectomy.The same procedure was completed successfully using backup lens with the same iol model and diopter size.No additional information was provided to johnson and johnson surgical vision, inc.
Additional Manufacturer Narrative
Device available for evaluation; returned to manufacturer on: 06/07/2018.Device evaluation: the z9002 lens was returned in its original package.Visual inspection using microscope magnification was performed: loose fibers/particles were observed on lens related the handling of the unit out of a sterile environment.Residues of lubricant material and material looks like body fluids were observed on lens surface.One of the haptics was observed slightly distorted.No damaged was observed to the other haptic.No scratches were also observed on lens.The complaint issue reported was not verified.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 no additional investigation requests for 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 johnson & johnson surgical vision, inc.Has been submitted.

• Brand Name: TECNIS CL
• Common Device Name: MONOFOCAL IOLS
• Manufacturer (Section D): JOHNSON AND JOHNSON SURGICAL VISION, INC.; santa ana CA
• MDR Report Key: 7517399
• Report Number: 2648035-2018-00714
• Device Sequence Number: 1385881
• Product Code: HQL
• UDI-Device Identifier: 05050474530621
• UDI-Public: (01)05050474530621(17)211115
• Combination Product (Y/N): Y
• Initial Reporter State: TX
• 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
• Report Date (Section B): 07/24/2018
• Report Date (Section F): 01/01/2005

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: 11/15/2021
• Device Model Number: Z9002
• Device Catalogue Number: Z900200165
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/07/2018
• Was the Report Sent to FDA?: Yes
• Date Report to Manufacturer: 01/10/2005
• Initial Date Received by Manufacturer: 04/16/2018
• Supplement Date Received by Manufacturer: 07/05/2018
• Initial Report FDA Received Date: 05/16/2018
• Supplement Report FDA Received Date: 07/24/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Date Report Sent to FDA: 01/01/2005