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

Model Number	PCB00
Medical Device Problem Code	Contamination /Decontamination Problem (2895)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	07/18/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
If implanted; give date: not applicable, lens was not implanted.If explanted; give date: not applicable, lens was not implanted.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.
Event or Problem Description
It was reported that a hair was found inside the applicator (injector) of the pcb00 intraocular lens (iol) upon opening the package.There was no patient contact as it was noticed during handling, but prior to insertion.No additional information provided.
Additional Manufacturer Narrative
Device available for evaluation? yes.Returned to manufacturer on: 9/17/2018.Device returned to manufacturer? yes.Device evaluation: the pcb00 device was received in the packaging box inside an opened pouch.The lens was observed under microscope and a long fiber like a black hair was observed on the device body.The fiber (hair) was analyzed by fourier transform infrared (ftir) spectroscopy.Visual examination revealed a dark fiber on the device.Ftir analysis indicated that the fiber is protein based like hair/fur, silk or wool.The complaint was verified, however, since the pouch was received open it is not possible to confirm if the origin of the particle observed is related to the manufacturing process.A product deficiency could be determined.The directions for use state that after opening the outer box of the device, examine the device package (pouch) for any damage, defect and to not use the device if the pouch is damaged or the seal is broken or if any damage or defect is found.Manufacturing record review: the manufacturing record was evaluated and no deviation or discrepancy was found related to the complaint issue reported.The product was manufactured and released according to specifications.The search revealed that no other complaints have been received for this production order.Labeling review: the directions for use (dfu) was reviewed.The dfu adequately provides instructions, precautions, along with warnings for the proper use and handling of the product.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.
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.; santa ana CA 92705
• MDR Report Key: 7798733
• Report Number: 2648035-2018-01121
• Device Sequence Number: 120663
• Product Code: HQL
• UDI-Device Identifier: 05050474558373
• UDI-Public: (01)05050474558373(17)210403
• Combination Product (Y/N): Y
• Initial Reporter Country: CA
• PMA/510(K) Number: P980040
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 11/02/2020
• 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: 04/03/2021
• Device Model Number: PCB00
• Device Catalogue Number: PCB0000255
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/17/2018
• Was the Report Sent to FDA?: No
• Date Report to Manufacturer: 01/10/2005
• Initial Date Received by Manufacturer: 07/23/2018
• Supplement Date Received by Manufacturer: 10/16/2018; 10/25/2020
• Initial Report FDA Received Date: 08/20/2018
• Supplement Report FDA Received Date: 11/08/2018; 11/02/2020
• 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