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

Model Number	ZCB00
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	11/06/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
If implanted; give date: n/a (not applicable).No patient contact.If explanted; give date: n/a (not applicable).No patient contact.Device evaluation: product testing could not be performed because the product was discarded by the customer.The customer's reported complaint could not be confirmed.Manufacturing records review: during the manufacturing record review of the production order for this serial number, no product deficiency was identified.The documentation shows that the production order was manufactured according to specifications.Historical data analysis: a search of complaints revealed no additional investigation request 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: as a result of the investigation there is no indication of a product quality deficiency.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.
Event or Problem Description
It was initially reported that a zcb00, 24.5 diopter intraocular lens (iol) haptic was broken.Through follow additional information was provided, it learnt that one of the haptics was found to be torn at the distal point of the arm upon opening the package.The lens was never loaded into the cartridge and there was no patient contact.The lens was discarded by the surgery center.No other information was provided.
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 AND JOHNSON SURGICAL VISION, INC.; santa ana CA
• MDR Report Key: 8131595
• Report Number: 2648035-2018-01562
• Device Sequence Number: 16206350
• Product Code: HQL
• UDI-Device Identifier: 05050474531802
• UDI-Public: (01)05050474531802(17)220414
• Combination Product (Y/N): Y
• Initial Reporter State: CA
• 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: Nurse
• Type of Report: Initial,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?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 04/14/2022
• Device Model Number: ZCB00
• Device Catalogue Number: ZCB0000245
• Was Device Available for Evaluation?: No
• 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: 10/25/2020
• Initial Report FDA Received Date: 12/04/2018
• Supplement Report FDA Received Date: 11/05/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Date Report Sent to FDA: 01/01/2005