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
Additional information: from the 79 events: cartridge crack, lens damaged ¿ 4, cartridge damaged, difficult to use, lens damaged ¿ 6, cartridge damaged, difficult to use, lens damaged, override ¿ 1, cartridge damaged, haptic damaged ¿ 1, cartridge damaged, iol torn, lens damaged ¿ 1, cartridge damaged, lens damaged ¿ 1, cartridge tip cracked/ damaged, haptic damaged, override ¿ 2, cosmetic issues ¿ 3, cosmetic issues, iol partially delivered, stuck in cartridge ¿ 1, cosmetic issues, override ¿ 1, delivery issue, haptic damaged, iol torn ¿ 1, difficult to use, haptic detached ¿ 1, difficult to use, iol torn ¿ 1, difficult to use, lens damaged ¿ 1, haptic damaged ¿ 17, haptic damaged, iol partially delivered ¿ 1, haptic damaged, iol torn ¿ 3, haptic damaged, loading issues ¿ 2, haptic damaged, override, stuck in cartridge ¿ 4, haptic detached ¿ 1, iol partially delivered, iol torn, override, stuck in cartridge ¿ 1, iol partially delivered, iol torn, stuck in cartridge ¿ 1, iol torn ¿ 15, iol torn, stuck in cartridge ¿ 4, lens damaged ¿ 3, lens damaged, override - 2.Serial numbers of suspect products: (b)(4).61 investigations were completed and 18 are pending for the time period.From the 61 completed investigations: cosmetic issues, stuck in cartridge ¿ 1, haptic damaged ¿ 1, haptic damaged, haptic detached ¿ 1, haptic damaged, haptic detached, iol torn ¿ 2, haptic damaged, haptic detached, lens damaged ¿ 1, haptic damaged, iol torn ¿ 1, haptic damaged, lens damaged ¿ 1, iol torn ¿ 1, stuck in cartridge ¿ 1, lens cut ¿ 4, lens cut, haptic damaged ¿ 15, lens cut, haptic damaged, haptic detached ¿ 2, lens cut, haptic detached ¿ 3, lens cut, iol torn ¿ 1, no issues identified ¿ 2, no product returned - 24.In the investigation it was concluded that products met manufacturing release criteria and no product deficiency was identified.A review of records related to the device including labeling, complaint trending, and risk documentation will be performed.Upon completion of this review, if there is any further relevant information obtained, a supplemental medwatch will be filed.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.
Event or Problem Description
This report summarizes 79 malfunction events.The events were related to lens damage.There were no patient injuries reported associated to the events.
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 (b)(4) and capa (b)(4).
Additional Manufacturer Narrative
Additional information: there are 19 investigations completed during this period.Breakdown of 19 investigations with respective serial numbers are as follows: (b)(4) no product returned (b)(4) no product returned (b)(4) lens cut (b)(4) haptic damaged, iol torn (b)(4) haptic detached, lens damaged (b)(4) haptic damaged (b)(4) cosmetic issues (b)(4) lens cut, haptic damaged, haptic detached (b)(4) haptic detached (b)(4) no product returned (b)(4) lens cut (b)(4) no product returned (b)(4) haptic damaged, haptic detached, iol torn (b)(4) iol torn (b)(4) no product returned (b)(4) no product returned (b)(4) no product returned (b)(4) no product returned (b)(4) lens cut, haptic damaged 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.

• 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: 10003452
• Report Number: 2648035-2020-00396
• Device Sequence Number: 19662841
• 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: 79
• Summary Report (Y/N): Y
• Reporter Type: Manufacturer
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 10/28/2020
• 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: 04/27/2020
• Supplement Report FDA Received Date: 07/22/2020; 10/28/2020
• Patient Sequence Number: 1
• Date Report Sent to FDA: 01/01/2005