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

Model Number	Z9002
Medical Device Problem Code	Separation Problem (4043)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	10/22/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Age/date of birth: unknown/not provided.Sex/gender: unknown/ not provided.If implanted, give date: not applicable, as lens was removed/replaced during the same procedure.If explanted, give date: not applicable, as lens was removed/replaced during the same procedure.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.
Event or Problem Description
It was reported that when lens was being inserted into the eye, it was noticed that the haptic was torn off.There was patient contact but no harm to patient.Another lens, same model and diopter was used for the replacement.No other information was provided.
Additional Manufacturer Narrative
Device available for evaluation: yes, device returned to manufacturer on: 11/29/2018, device returned to manufacturer: yes.Device evaluation: the product was returned for investigation and revealed viscoelastic on the surface of the lens indicating that the lens was handled.The lens had a detached haptic (loop detached) that was not received with the product returned.The other haptic (loop) looked in good condition.The reported issue was verified; however, a product quality deficiency could not be determined due to the condition of the lens that was received.Manufacturing record review: manufacturing records were reviewed.The product was manufactured and released according to specifications.A search in complaint history revealed that no similar complaints have been received for this production order number.Labeling review: the labeling review was completed.The directions for use (dfu) adequately provide instructions, precautions, along with warnings for the proper use and handling of the product.Conclusion: based on the results of the investigation, a product quality deficiency could not be determined.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.
Additional Manufacturer Narrative
This correction mdr is being submitted to address inaccurate information in section f on the xml version of the previous submission caused by a software glitch in the transmission process.The internal non-conformance numbers for this software issue are (b)(4) and capa (b)(4).

• Brand Name: TECNIS CL
• Common Device Name: MONOFOCAL IOLS
• Manufacturer (Section D): JOHNSON AND JOHNSON SURGICAL VISION, INC.; 1700 east st. andrew place; santa ana CA 92705
• MDR Report Key: 8081893
• Report Number: 2648035-2018-01484
• Device Sequence Number: 1500532
• Product Code: HQL
• UDI-Device Identifier: 05050474530591
• UDI-Public: (01)05050474530591(17)220630
• Combination Product (Y/N): Y
• Initial Reporter State: FL
• 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): 11/05/2020
• 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: Health Professional
• Device Expiration Date: 06/30/2022
• Device Model Number: Z9002
• Device Catalogue Number: Z900200150
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/29/2018
• Was the Report Sent to FDA?: No
• Date Report to Manufacturer: 01/10/2005
• Initial Date Received by Manufacturer: 10/23/2018
• Supplement Date Received by Manufacturer: 12/17/2018; 10/25/2020
• Initial Report FDA Received Date: 11/16/2018
• Supplement Report FDA Received Date: 01/11/2019; 11/05/2020
• 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