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

Model Number	Z9002
Medical Device Problem Code	Device Damaged Prior to Use (2284)
Health Effect - Clinical Code	No Patient Involvement (2645)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
If implanted, give date: not applicable, as the lens was not implanted.If explanted, give date: not applicable, as the lens was not implanted.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.
Event or Problem Description
It was reported that a z9002, 15.0 diopter intraocular lens (iol) was damaged when removed from packaging.There was no patient contact.No additional information was provided.
Additional Manufacturer Narrative
Additional information: device available for evaluation ¿ yes, returned to manufacturer on 2/4/2019.Device returned to manufacturer ¿ yes.Device evaluation: the return product z9002 was received and visually inspected.Results revealed one lens haptic observed distorted.There is no issue with the other lens haptic.Some particles and viscoelastic residues were observed in the lens optic but no damages.The reported issue was verified as haptic damaged.However, there is no evidence to suggest that the complaint sample has been affected by the manufacturing process.Manufacturing record review: the manufacturing process record was evaluated and no deviation was found related to the complaint issue reported.The product was manufactured and released according to specifications.A search revealed that revealed one (1) additional investigation request for this purchase order (po) number.However the investigation request was subsequently cancelled as the issue was related to use error.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: the reported issue was verified.However, there is no evidence to suggest that the complaint sample has been affected by the manufacturing process.As a result of the investigation there is no indication of a product quality deficiency.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 nr-0148919 and capa-010215.

• 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: 8132003
• Report Number: 2648035-2018-01564
• Device Sequence Number: 1721956
• Product Code: HQL
• UDI-Device Identifier: 05050474530591
• UDI-Public: (01)05050474530591(17)220615
• Combination Product (Y/N): Y
• Initial Reporter State: CO
• 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: 06/15/2022
• Device Model Number: Z9002
• Device Catalogue Number: Z900200150
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/04/2019
• Was the Report Sent to FDA?: No
• Date Report to Manufacturer: 01/10/2005
• Initial Date Received by Manufacturer: 11/07/2018
• Supplement Date Received by Manufacturer: 02/05/2019; 10/25/2020
• Initial Report FDA Received Date: 12/05/2018
• Supplement Report FDA Received Date: 03/01/2019; 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