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 34 events: haptic damaged 8.Iol torn 8.Lens damaged 3.Lens damaged, stuck in cartridge 6.Haptic detached, loading issues 1.Haptic detached, missing component 1.Cartridge crack, lens damaged 2.Cartridge damaged, cosmetic issues, inserter problem, override, stuck in cartridge 1.Cosmetic issues 1.Handling problem, improperly loaded, lens damaged, stuck in cartridge 1.Haptic damaged, stuck in cartridge 1.Lens damaged, override 1.Serial numbers of suspect products: (b)(4).11 investigations were completed and 23 are pending for the time period.From the 11 completed investigations: haptic damaged, haptic detached, stuck in cartridge 1.Haptic damaged, iol torn 2.Haptic damaged 2.Lens cut, haptic damaged, haptic detached 1.Lens cut, haptic damaged, iol torn 1.Lens cut, haptic damaged, haptic detached, lens damaged 1.No product returned 5.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 file.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 34 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: additional information was received, and it was learnt that one of the unknown serial number that was reported in previous quarter is now a known serial number.The serial number is (b)(6).There were 23 investigations completed during this period.Breakdown of 23 investigations with respective lot numbers are as follows: 1019341908, lens cut, haptic damaged; 1062081906, no product returned; unknown, no product returned; 1063841909, lens cut, haptic damaged; 1040461707, dc-cosmetic issues, iol torn; 1017421909, dc-haptic damaged, iol torn; 1055551906, dc-haptic damaged, haptic detached; 1029101811, dc-haptic detached; 1023521905, dc-haptic damaged, lens damaged; 1059981812, lens cut, iol torn; unknown, no product returned; 1099201907, no product returned; 1059801902, no product returned; 1037631908, no product returned; 1002171910, no product returned; 1064731909, no product returned; 1054861907, no product returned; 1111911703, no product returned; 1098321909, no product returned; 1046311906, dc-haptic detached, lens damaged; 1079771811, dc-haptic damaged, lens damaged; 1069691909, dc-haptic damaged, stuck in cartridge; 1012551905, dc-lens 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: 9645545
• Report Number: 2648035-2020-00093
• Device Sequence Number: 2791039
• 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: 34
• 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: 01/30/2020
• Supplement Report FDA Received Date: 04/27/2020; 10/28/2020
• Patient Sequence Number: 1
• Date Report Sent to FDA: 01/01/2005