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: breakdown of 30 events is as follows: dc-cosmetic issues: 2.Dc-device partially delivered,dc-haptic damaged: 3.Dc-device partially delivered,dc-haptic damaged : 1.Dc-device partially delivered,dc-haptic detached: 1.Dc-device partially delivered,dc-iol torn: 1.Dc-haptic damaged: 6.Dc-haptic damaged,dc-loading issues: 1.Dc-haptic detached: 4.Dc-haptic detached,dc-loading issues: 1.Dc-iol torn 2.Dc-iol torn,dc-override 1.Dc-iol torn,dc-stuck in cartridge 2.Dc-lens damaged 5.Serial number of the suspect product: (b)(4) 1, (b)(4) 1, (b)(4) 1, (b)(4) 1, (b)(4) 1, (b)(4) 1, (b)(4) 1, (b)(4) 1, (b)(4) 1, (b)(4) 1, (b)(4) 1, (b)(4) 1, (b)(4) 1, (b)(4) 1, (b)(4) 1, (b)(4) 1, (b)(4) 1, (b)(4) 1, (b)(4) 1, (b)(4) 1, (b)(4) 1, (b)(4) 1, (b)(4) 1, (b)(4) 1, (b)(4) 1, (b)(4) 1, (b)(4) 1, (b)(4) 1, (b)(4) 1, (b)(4) 1.18 investigations were completed, and 12 investigations are pending from this period.Breakdown of 18 completed investigations: dc-haptic damaged,dc-haptic detached: 1.Dc-haptic damaged,dc-iol torn: 2.Dc-haptic damaged,dc-stuck in cartridge: 2.Dc-override,dc-stuck in cartridge: 1.Lens cut,dc-cosmetic issues,dc-haptic damaged,dc-iol torn: 1.Lens cut,dc-haptic damaged: 4.Lens cut,dc-haptic damaged,dc-haptic detached: 2.Lens cut,dc-haptic damaged,dc-lens damaged: 1.Lens cut,dc-haptic detached: 2.No product returned: 2.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 30 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 12 investigations completed during this period.Breakdown of 12 investigations with respective serial numbers are as follows: (b)(6) lens cut, haptic damaged, iol torn, (b)(6) haptic damaged, iol torn, (b)(6) no product returned, (b)(6) lens cut, haptic damaged, (b)(6) haptic detached, (b)(6) haptic damaged, lens damaged, (b)(6) cosmetic issues, iol torn, (b)(6) lens cut, haptic detached, (b)(6) no product returned, (b)(6) cosmetic issues, haptic damaged, (b)(6) haptic damaged, (b)(6) haptic detached, 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: 10753226
• Report Number: 2648035-2020-00791
• Device Sequence Number: 19662730
• 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: 30
• Summary Report (Y/N): Y
• Reporter Type: Manufacturer
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 01/30/2021

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
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 10/29/2020
• Supplement Report FDA Received Date: 01/31/2021
• Patient Sequence Number: 1