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

Model Number	PCB00
Medical Device Problem Codes	Difficult or Delayed Positioning (1157); Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	06/15/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
If implanted, give date: not applicable as the lens was not implanted.If explanted, give date: not applicable as the lens was not implanted and therefore not explanted.(b)(6).All pertinent information available to johnson and johnson surgical vision, inc.Has been submitted.
Event or Problem Description
It was reported that during the implantation of the intraocular lens (pcb00 14.5 diopter) the haptic got stuck in the cartridge.Reportedly, the lens had patient contact but there was no injury.No further information was provided.
Additional Manufacturer Narrative
Device available for evaluation, returned to manufacturer on: 08/25/2018.Device evaluation: the device was received at the manufacturing site for investigation.A visual inspection and evaluation using magnification was performed.The pcb00 product was received in the original package.The plunger and pushrod were observed in advanced position.Residues of viscoelastic material was observed on cartridge.Lens was returned with the preloaded device.No damaged was observed to the cartridge.No assembly error and/or defect were observed in the preloaded device related to manufacturing process.The condition in which the sample returned is consistent with a product that was handled and prepared for a surgical process.The complaint issue reported could not be verified.Manufacturing record review: manufacturing record review of the production order and related document revealed that the product was manufactured and released according to specification.Historical data analysis: the search in complaint history revealed one additional complaint was received for this production order number which the results revealed that the product was manufactured according to specification and no product quality deficiency was identified and it was not related to this issue.Labeling review: the directions for use (dfu) was reviewed.The dfu adequately provides instructions and precautions for the proper use and handling of the product.Conclusion: based on the investigation results, there is no indication of a product quality deficiency and the reported complaint 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 SURGICAL VISION, INC.; santa ana CA
• MDR Report Key: 7685088
• Report Number: 2648035-2018-00990
• Device Sequence Number: 634546
• Product Code: HQL
• UDI-Device Identifier: 05050474558151
• UDI-Public: (01)05050474558151(17)200720
• Combination Product (Y/N): Y
• PMA/510(K) Number: P980040
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional,u
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 10/30/2020
• 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: 07/20/2020
• Device Model Number: PCB00
• Device Catalogue Number: PCB0000145
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/25/2018
• Was the Report Sent to FDA?: No
• Date Report to Manufacturer: 01/10/2005
• Initial Date Received by Manufacturer: 06/18/2018
• Supplement Date Received by Manufacturer: 09/24/2018; 10/25/2020
• Initial Report FDA Received Date: 07/13/2018
• Supplement Report FDA Received Date: 10/18/2018; 10/30/2020
• 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