MAUDE Adverse Event Report: JOHNSON AND JOHNSON SURGICAL VISION TECNIS ITEC PRELOADED 1-PIECE IOL; MONOFOCAL IOLS

Model Number	PCB00
Medical Device Problem Code	Contamination /Decontamination Problem (2895)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	08/21/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
If explanted, give date: not applicable, as the lens remains implanted.  it was indicated that the device is not returning for evaluation as it remains implanted in patient eye; 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 and johnson surgical vision has been submitted.
Event or Problem Description
It was reported that after the intraocular lens (iol) was implanted into the patient¿s right eye, multiple lint fibers attached to the underside of the lens were noticed.The foreign material was removed by aspiration and no injury to the patient or wound enlargement was necessary.The lens remains implanted.No medical intervention was required.The patient was reported doing fine.No further 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 ITEC PRELOADED 1-PIECE IOL
• Common Device Name: MONOFOCAL IOLS
• Manufacturer (Section D): JOHNSON AND JOHNSON SURGICAL VISION; santa ana CA
• MDR Report Key: 7884656
• Report Number: 2648035-2018-01244
• Device Sequence Number: 2726546
• Product Code: HQL
• UDI-Device Identifier: 05050474558458
• UDI-Public: (01)05050474558458(17)181124
• Combination Product (Y/N): Y
• Initial Reporter State: OR
• Initial Reporter Country: US
• PMA/510(K) Number: P980040
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 11/03/2020
• 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: 11/24/2018
• Device Model Number: PCB00
• Device Catalogue Number: PCB0000295
• 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: 08/21/2018
• Supplement Date Received by Manufacturer: 10/25/2020
• Initial Report FDA Received Date: 09/18/2018
• Supplement Report FDA Received Date: 11/03/2020
• 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