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 (1120)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	08/22/2018
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/lot 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, it was noted to have an unidentifiable foreign object attached to the underside of the lens.The foreign object was removed and retained.There was no injury to patient.The patient is doing fine postop.No further information provided.
Additional Manufacturer Narrative
Device available for evaluation: yes.Returned to manufacturer on: 10/9/2018.Device returned to manufacturer: yes.Device evaluation: the product was returned to the manufacturing site for evaluation.Fiber was sent for further investigation.Ftir analysis indicates that the foreign material is consistent with a cellulosic material (e.G.Cotton, rayon, lint).Potential and indirect exposure to cellulosic material is possible; however, throughout the manufacturing processes there are various cleaning operations and 100% visual inspection utilizing a microscope magnification steps that would have identified and discarded a lens with a similar particulate, as required by our approved procedures.The manufacturing process is performed inside a regulated clean room class 6 manufacturing room that requires full gowning before entering the room.The manufacturing data confirmed that no process deviation could be undetected by our control process.The complaint issue reported was verified.It, however, could not be fully confirmed if the particle identified was from the manufacturing process, since the device was handled and prepare for surgical process.Based on the analysis of the return, there is no indication of a product quality deficiency.Manufacturing records review: the manufacturing records for the intraocular lens were reviewed.The product was manufactured and released according to specification.A search revealed that no similar investigations have been received for this production order.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.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 AND JOHNSON SURGICAL VISION; santa ana CA
• MDR Report Key: 7887881
• Report Number: 2648035-2018-01248
• Device Sequence Number: 16825932
• Product Code: HQL
• UDI-Device Identifier: 05050474558106
• UDI-Public: (01)05050474558106(17)191213
• 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,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: 12/13/2019
• Device Model Number: PCB00
• Device Catalogue Number: PCB0000120
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/09/2018
• Was the Report Sent to FDA?: No
• Date Report to Manufacturer: 01/10/2005
• Initial Date Received by Manufacturer: 08/22/2018
• Supplement Date Received by Manufacturer: 10/23/2018; 10/25/2020
• Initial Report FDA Received Date: 09/18/2018
• Supplement Report FDA Received Date: 11/13/2018; 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: 70 YR
• Date Report Sent to FDA: 01/01/2005