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

Model Number	Z9002
Medical Device Problem Code	Detachment Of Device Component (1104)
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	05/16/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
If implanted, give date: not applicable, as lens was removed/replaced in the initial surgery.If explanted, give date: not applicable, as lens was removed/replaced in the initial surgery.(b)(4).All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.
Event or Problem Description
It was reported that the tecnis monofocal intraocular lens (model z9002, +18.0 diopter) was implanted and then the surgeon realized that the posterior capsule would not support the lens hence it was removed and replaced with an anterior chamber lens (non-johnson&johnson lens).Both the haptics were detached during the removal process.Additional information was received and it was learnt that during the removal of the lens, the incision was enlarged.No capsule tear and no other medical/surgical intervention was performed.The patient was reported doing good when discharged.No further information was provided.
Additional Manufacturer Narrative
Device available for evaluation: yes, returned to manufacturer on: 07/20/2018.Device returned to manufacturer: yes.Device evaluation: the product was returned to the manufacturing site for evaluation.The lens was observed under microscope, and only half of the lens was returned to inspect, and the half that we receive had the haptic bent.The lens optic was observed cut in half and with residue.The complaint issue reported as haptic detached was not verified however due the condition of the lens received the complaint could not be related to the manufacturing process it could be related to the handling process; therefore, a product quality deficiency was not identified.Manufacturing records review: the manufacturing records for the intraocular lens were reviewed.The product was manufactured and released according to specification.A search on complaints revealed that no other complaints were received for this production order number.Labeling review: the directions for use (dfu) was reviewed.The dfu adequately provides instructions and precautions along with warnings for the proper use and handling of the device.As a result of the investigation there is no indication of a product quality deficiency and the reported issue could not be verified.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.

• Brand Name: TECNIS CL
• Common Device Name: MONOFOCAL IOLS
• Manufacturer (Section D): JOHNSON & JOHNSON SURGICAL VISION, INC.; santa ana CA
• MDR Report Key: 7644797
• Report Number: 2648035-2018-00916
• Device Sequence Number: 275109
• Product Code: HQL
• UDI-Device Identifier: 05050474530652
• UDI-Public: (01)05050474530652(17)220718
• Combination Product (Y/N): Y
• Initial Reporter State: IL
• 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: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/24/2018
• 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?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Physician
• Device Expiration Date: 07/18/2022
• Device Model Number: Z9002
• Device Catalogue Number: Z900200180
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/20/2018
• Was the Report Sent to FDA?: Yes
• Date Report to Manufacturer: 01/10/2005
• Initial Date Received by Manufacturer: 05/31/2018
• Supplement Date Received by Manufacturer: 08/03/2018
• Initial Report FDA Received Date: 06/28/2018
• Supplement Report FDA Received Date: 08/24/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: PSCST30 CARTRIDGE, LOT UNKNOWN
• Outcome Attributed to Adverse Event: Required Intervention
• Date Report Sent to FDA: 01/01/2005