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

Model Number	PCB00
Medical Device Problem Code	Crack (1135)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	07/24/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
If implanted, explanted, give date: not applicable, as lens was not implanted.All pertinent information available to johnson and johnson vision has been submitted.
Event or Problem Description
It was reported that tecnis itec preloaded 1-piece intraocular lens (model pcb00, +10.5 diopter) had a defective cartridge where the tip was reported cracked.There was no patient contact reported.No further information provided.
Additional Manufacturer Narrative
Device available for evaluation: yes.Returned to manufacturer on: 8/31/2018.Device returned to manufacturer: yes.The product was returned to the manufacturing site for evaluation.The returned pcb00 device was observed with the plunger in completely advanced position and locked.The pcb00 device was observed under microscope and scarce amount of lubricant residues were observed inside the device.No lens was observed inside the pcb00 device.The cartridge tip was observed deformed but not cracked.This condition could be caused by the delivery of the lens due to the scarce amount of viscoelastic used.Dfu states to completely fill the viewing window with ovd.The complaint was verified in the sample return however it could be related to the handling process.No product quality deficiency was identified.The complaint cannot be confirmed.The manufacturing records for the intraocular lens were reviewed.The product was manufactured and released according to specification.A search on complaints revealed that no other complaints were received for this production order number.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 and the reported issue could not be 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 nr-0148919 and capa-010215.

• Brand Name: TECNIS ITEC PRELOADED 1-PIECE IOL
• Common Device Name: MONOFOCAL IOLS
• Manufacturer (Section D): JOHNSON AND JOHNSON VISION; santa ana CA
• MDR Report Key: 7815629
• Report Number: 2648035-2018-01140
• Device Sequence Number: 11059900
• Product Code: HQL
• UDI-Device Identifier: 05050474558076
• UDI-Public: (01)05050474558076(17)210111
• Combination Product (Y/N): Y
• Initial Reporter State: CT
• 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): 11/02/2020
• 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: 01/11/2021
• Device Model Number: PCB00
• Device Catalogue Number: PCB0000105
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/31/2018
• Was the Report Sent to FDA?: No
• Date Report to Manufacturer: 01/10/2005
• Initial Date Received by Manufacturer: 07/27/2018
• Supplement Date Received by Manufacturer: 09/12/2018; 10/25/2020
• Initial Report FDA Received Date: 08/27/2018
• Supplement Report FDA Received Date: 09/21/2018; 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