MAUDE Adverse Event Report: JOHNSON & JOHNSON SURGICAL VISION, INC. TECNIS 1-PIECE; MONOFOCAL IOLS

Model Number	ZCB00
Medical Device Problem Code	Scratched Material (3020)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	12/05/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Not applicable, as lens was removed/replaced in the initial surgery.Not applicable, as lens was removed/replaced in the initial surgery.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.
Event or Problem Description
It was reported that an zcb00 intraocular lens was implanted into the patients right eye on (b)(6) 2018, and removed during the same procedure due to a scratch on the lens observed by the surgeon.The procedure was successfully completed using a back-up lens.There were no injuries and no additional intervention required.No additional information was provided.
Additional Manufacturer Narrative
Device available for evaluation: yes, returned to manufacturer on: 01/22/2019, device returned to manufacturer: yes.Device evaluation: the sample was received inside the lens case in the packaging box.The lens was observed under microscope and it was received cut in the middle with one half missing.A haptic detached and one half lens with the haptic, was received.The condition of the lens is typically of a lens that was cut for removal.Due the condition of the lens received the complaint could not be verified.A product quality deficiency was not identified.Manufacturing records review: the manufacturing records for the device were reviewed.The review identified no non-conformance reports (nc) associated to this production order.The product was manufactured and released according to specifications.Historical data analysis: a search in complaint history revealed no other complaint has been received for this production order number.Labeling review: the labeling review was completed and revealed that the directions for use (dfu) provide the customer with proper usage instructions and guidelines.Conclusion: based on the investigation results there is no indication of a product quality deficiency.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-0148919 and capa-010215.

• Brand Name: TECNIS 1-PIECE
• Common Device Name: MONOFOCAL IOLS
• Manufacturer (Section D): JOHNSON & JOHNSON SURGICAL VISION, INC.; santa ana CA 92705
• MDR Report Key: 8241293
• Report Number: 2648035-2019-00060
• Device Sequence Number: 16691709
• Product Code: HQL
• UDI-Device Identifier: 05050474531864
• UDI-Public: (01)05050474531864(17)220628
• Combination Product (Y/N): Y
• Initial Reporter State: MD
• Initial Reporter Country: US
• PMA/510(K) Number: P980040
• 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
• Report Date (Section B): 11/06/2020
• 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: Health Professional
• Device Expiration Date: 06/28/2022
• Device Model Number: ZCB00
• Device Catalogue Number: ZCB0000275
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/22/2019
• Was the Report Sent to FDA?: No
• Date Report to Manufacturer: 01/10/2005
• Initial Date Received by Manufacturer: 12/17/2018
• Supplement Date Received by Manufacturer: 02/05/2019; 10/25/2020
• Initial Report FDA Received Date: 01/11/2019
• Supplement Report FDA Received Date: 02/14/2019; 11/06/2020
• 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 1MTEC LOT: CD10990
• Date Report Sent to FDA: 01/01/2005