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

Model Number	Z9002
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Breakdown of 19 events is as follows: cartridge tip cracked/damaged, cosmetic issues 1, delivery issue, stuck in cartridge 1, haptic damaged 5, haptic damaged,dc-loading issues 2, haptic detached 1, iol torn 6, lens damaged 1, stuck in cartridge 1, unspecified/other with patient involvement 1.Serial number of the suspect products: (b)(4).11 investigations were completed and 8 investigations are pending from this period.Breakdown of completed investigations: (b)(4) haptic damaged, (b)(4) haptic damaged,loading issues,stuck in cartridge, (b)(4) no product returned, (b)(4) no issues identified, (b)(4) lens cut, (b)(4) lens cut,haptic damaged, (b)(4) lens cut,haptic damaged, (b)(4) lens cut,haptic damaged,ol torn, (b)(4) haptic detached, (b)(4) no product returned, (b)(4) lens cut,haptic damaged.The investigation concluded that the product met manufacturing release criteria.A review of the records related to the device including complaint trend and risk documentation will be performed.Upon completion of this review, if there is any further relevant information obtained then a supplemental medwatch will be filed.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.
Event or Problem Description
This report summarizes 19 malfunction events.The events were related to lens damage.There were no patient injuries reported associated to the events.
Additional Manufacturer Narrative
Additional information: there are 7 investigations completed during this period.Breakdown of 7 investigations with respective lot/serial numbers are as follows: 1044502002 haptic damaged 1031671912 lens cut, iol torn 1025802001 haptic damaged, lens damaged 1022521910 iol torn, lens damaged 1047951909 no issues identified 1023331601 lens cut,haptic detached 1028211909 lens cut,haptic damaged,haptic detached the investigations concluded that product met manufacturing release criteria and no product deficiency was identified.All pertinent information available to johnson & johnson surgical vision, inc.That was received during the time period that covers this voluntary malfunction summary report has been submitted.
Additional Manufacturer Narrative
This correction mdr is being submitted to address inaccurate information in section f and g.4 date 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 & JOHNSON SURGICAL VISION, INC.; 1700 e st andrew place; santa ana CA 92705
• MDR Report Key: 10302501
• Report Number: 2648035-2020-00522
• Device Sequence Number: 14097451
• Product Code: HQL
• UDI-Device Identifier: 05050474530720
• UDI-Public: (01)05050474530720
• Combination Product (Y/N): Y
• PMA/510(K) Number: P880081
• Number of Events Summarized: 19
• Summary Report (Y/N): Y
• Reporter Type: Manufacturer
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 11/16/2020
• 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: No Information
• Device Model Number: Z9002
• Device Catalogue Number: Z900200215
• Was the Report Sent to FDA?: No
• Date Report to Manufacturer: 01/10/2005
• Initial Date Received by Manufacturer: 01/14/2005
• Supplement Date Received by Manufacturer: 01/14/2005; 10/25/2020
• Initial Report FDA Received Date: 07/21/2020
• Supplement Report FDA Received Date: 10/29/2020; 11/16/2020
• Patient Sequence Number: 1
• Date Report Sent to FDA: 01/01/2005