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

Model Number	Z9002
Medical Device Problem Code	Separation Problem (4043)
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	11/06/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
If implanted; give date: not applicable as the lens was inserted and removed.If explanted; give date: not applicable as the lens was inserted and removed.(b)(4).An attempt has been made to obtain missing information; however, to date, no response has been received.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.
Event or Problem Description
It was reported that the z9002 intraocular lens (iol) was inserted and removed from the patient's operative eye, due to a missing haptic.The account commented that haptic was possibly amputated during loading.An incision enlargement was required.The procedure was completed successfully using a back-up lens.No further information was provided.
Additional Manufacturer Narrative
Additional data: based on new information received, lens will not be available for investigation.Therefore, product will not be returned.It was also noted that there was no surgical intervention was required.The intraocular lens (iol) is not returning for evaluation; therefore, a failure analysis of the complaint device cannot be completed.A review of the device history record, labeling, complaint trending, and risk documentation for this device will be performed.Upon completion of the review, if there is any further relevant information a supplemental medwatch will be filed.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.
Additional Manufacturer Narrative
Additional information: device available for evaluation ¿ yes, returned to manufacturer on 01/04/2019.Device returned to manufacturer ¿ yes.Device evaluation: the intraocular lens (iol) was returned to the manufacturing site for evaluation.Lens returned cut in two pieces.One of the haptic was observed damaged/distorted.The other haptic was observed detached.The detached haptic piece was not returned.The condition in which the sample returned is consistent with a lens that was implanted and removed.The complaint issue reported was verified.Manufacturing records review: the manufacturing records for the intraocular lens were reviewed.The product was manufactured and released according to specification.A search revealed no additional investigation request 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.
Additional Manufacturer Narrative
This correction mdr is being submitted to address inaccurate information in section f 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-(b)(4) and capa-010215.

• Brand Name: TECNIS CL
• Common Device Name: MONOFOCAL IOLS
• Manufacturer (Section D): JOHNSON & JOHNSON SURGICAL VISION, INC.; santa ana CA 92705
• MDR Report Key: 8119016
• Report Number: 2648035-2018-01548
• Device Sequence Number: 1657007
• Product Code: HQL
• UDI-Device Identifier: 05050474530638
• UDI-Public: (01)05050474530638(17)220131
• Combination Product (Y/N): Y
• Initial Reporter State: TN
• 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,Followup,Followup
• Report Date (Section B): 11/05/2020
• 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?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 01/31/2022
• Device Model Number: Z9002
• Device Catalogue Number: Z900200170
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/04/2019
• Was the Report Sent to FDA?: No
• Date Report to Manufacturer: 01/10/2005
• Initial Date Received by Manufacturer: 11/06/2018
• Supplement Date Received by Manufacturer: 12/07/2018; 01/09/2019; 10/25/2020
• Initial Report FDA Received Date: 11/30/2018
• Supplement Report FDA Received Date: 01/05/2019; 01/31/2019; 11/05/2020
• 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: CARTRIDGE MODEL PSCST30, LOT: CD06113
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 60 YR
• Date Report Sent to FDA: 01/01/2005