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

Model Number	PCB00
Medical Device Problem Code	Contamination (1120)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	11/26/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
If implanted, give date: not applicable, as unknown if lens was implanted.If explanted, give date: not applicable, as unknown if lens was implanted.Hence, cannot be removed.Several attempts have been made to obtain missing information; however, no definitive response has been received.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.
Event or Problem Description
It was reported by the surgeon that a pcb00 intraocular lens (iol) during handling, but prior to insertion had a black hair or fiber in the cartridge.It was also stated that there was no adverse event, surgical intervention or patient injury involved in this event.No other information was provided.
Additional Manufacturer Narrative
Device available for evaluation: yes, returned to manufacturer on 1/22/2019, device returned to manufacturer: yes.Device evaluation: the pcb00 suspect product was received and revealed that the plunger was observed advanced towards the second mark.The lens was found advanced and stuck at the cartridge tube.Traces of what appears to be balanced salt solution are observed at the cartridge surface.Brownish stains are also observed; these were not reported by the customer.The product including the observed black hair or fiber described by the customer and brownish stains observed at the complaints laboratory were sent to our third-party analysis laboratory for identification by fourier transform infrared (ftir).Summary of the ftir results: ftir analysis indicates that the brown stains are consistent with a protein containing material such as skin.Ftir analysis indicates that the dark fiber is consistent with a cellulosic material (e.G.Cotton, rayon, lint).Based on the observations of the returned product there are indications the pcb00 was handled and probably had contact with the patient since the observed brownish stains are consistent with a protein containing material such as skin (per third-party laboratory ftir results).The reported issue was verified.A product quality deficiency could not be determined.Manufacturing record review: the manufacturing process record was evaluated and the devices were manufactured and released within specifications.A search revealed that no additional complaints were received from this production order.Labeling review: the labeling review was completed.The directions for use (dfu) adequately provide instructions, precautions, along with warnings for the proper use and handling of the product.Conclusion: as a result of the investigation the reported issue was verified, however 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, INC.; 1700 east st. andrew place; santa ana CA 92705
• MDR Report Key: 8259229
• Report Number: 2648035-2019-00095
• Device Sequence Number: 1833037
• Product Code: HQL
• UDI-Device Identifier: 05050474558199
• UDI-Public: (01)05050474558199(17)210831
• Combination Product (Y/N): Y
• Initial Reporter State: KY
• 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: Other
• 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: 08/31/2021
• Device Model Number: PCB00
• Device Catalogue Number: PCB0000165
• 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: 12/21/2018
• Supplement Date Received by Manufacturer: 01/31/2019; 10/25/2020
• Initial Report FDA Received Date: 01/17/2019
• Supplement Report FDA Received Date: 02/26/2019; 11/06/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Date Report Sent to FDA: 01/01/2005