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

Model Number	PCB00
Medical Device Problem Code	Failure to Eject (4010)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	03/05/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
If implanted; give date: not applicable as the iol was not implanted.If explanted; give date: not applicable as the iol was not implanted.It was indicated that the device is not returning for evaluation; therefore a failure analysis of the complaint device cannot be completed.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.
Event or Problem Description
It was reported while attempting to insert pcb00 14.0 diopter intraocular lens (iol) in the patient¿s ocular sinister (left eye) the lens would not deploy, stuck in the pre-loaded cartridge, and there was patient contact with the product.It was reported the lens was discarded, outcome does not significantly interfere with activities of daily life, and the patient has recovered.No additional information was provided to johnson & johnson surgical vision.
Additional Manufacturer Narrative
In initial report, "additional information" was selected as a type of report, however, it should have been left blank/not selected as it was an initial report.Device evaluation: product testing could not be performed because the product was discarded.A product quality deficiency could not be confirmed.The reported issue was not verified.Manufacturing records review: the manufacturing records for the product were reviewed, the product was manufactured and released according to specification.Historical data analysis: a search revealed that no additional/similar (as applicable) complaints for this order number.Have been received.Labeling review: the directions for use (dfu) were reviewed, the dfu adequately provides instructions and precautions along with warnings for the proper use and handling of the device.Conclusion: as a result, of the investigation there is no indication of a product malfunction or product quality deficiency.The reported issue was not 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 (b)(4) and capa-010215.

• Brand Name: TECNIS ITEC PRELOADED 1-PIECE IOL
• 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: 8530466
• Report Number: 2648035-2019-00473
• Device Sequence Number: 19207841
• Product Code: HQL
• UDI-Device Identifier: 05050474558144
• UDI-Public: (01)05050474558144(17)211016
• Combination Product (Y/N): Y
• Initial Reporter State: WI
• Initial Reporter Country: US
• PMA/510(K) Number: P980040
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,health profession
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 11/11/2020
• 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: 10/16/2021
• Device Model Number: PCB00
• Device Catalogue Number: PCB0000140
• 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: 03/26/2019
• Supplement Date Received by Manufacturer: 04/26/2019; 10/25/2020
• Initial Report FDA Received Date: 04/19/2019
• Supplement Report FDA Received Date: 05/16/2019; 11/12/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 67 YR
• Date Report Sent to FDA: 01/01/2005