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

Model Number	PCB00
Medical Device Problem Code	Failure to Eject (4010)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	02/25/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Additional information: if implanted; give date: not applicable as the iol was not implanted.If explanted; give date: not applicable as the iol was not implanted.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.
Event or Problem Description
It was reported when injecting a pcb00 25.5 diopter intraocular lens (iol) into the patient¿s operative eye customer account reported the lens began to advance and then stopped, and would no longer advance once halfway out of the cartridge.The lens did not fully inject into the eye and when withdrawn from the eye the implant remained in the cartridge; there was patient contact.A backup implant was opened to use instead, and no further action was taken.No additional information was provided.
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.
Additional Manufacturer Narrative
Additional information: section d-10: device available for evaluation: yes.Section d-10: returned to manufacturer on: 03/17/2020.Section h-3 device returned to manufacturer: yes.Device evaluation: the complaint product was returned in a plastic bag.The plunger was in a fully advanced position and the pushrod was exposed out of the cartridge tip.The cartridge was correctly engaged to the device.No assembly error and/or defect related to manufacturing process were observed.Visual inspection performed under microscope: a small amount of lubricating material residue was observed in the device.There was no lens returned inside nor outside the device.Due to the conditions in which the sample returned, and as no lens was received the reported issues were not verified.Based on the analysis, product quality deficiency was not identified.Manufacturing records review: the manufacturing records for the product were reviewed, the product was manufactured and released according to specification.Historical data analysis: a search revealed that no additional complaints for this production order number have been received.Conclusion: as a result, of the investigation there is no indication of a product malfunction or product quality deficiency.The reported issue was not verified.Attempts were made to contact the customer account requesting additional information however, to date no response has been received.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.

• Brand Name: TECNIS ITEC PRELOADED 1-PIECE IOL
• Common Device Name: MONOFOCAL IOLS
• Manufacturer (Section D): JOHNSON & JOHNSON SURGICAL VISION, INC.; 1700 e. st. andrew place; santa ana CA 92705
• MDR Report Key: 9884467
• Report Number: 2648035-2020-00287
• Device Sequence Number: 14151760
• Product Code: HQL
• UDI-Device Identifier: 05050474558373
• UDI-Public: (01)05050474558373(17)230115
• Combination Product (Y/N): Y
• Initial Reporter State: IN
• 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): 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: 01/15/2023
• Device Model Number: PCB00
• Device Catalogue Number: PCB0000255
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/17/2020
• Was the Report Sent to FDA?: No
• Date Report to Manufacturer: 01/10/2005
• Initial Date Received by Manufacturer: 02/25/2020
• Supplement Date Received by Manufacturer: 03/30/2020; 10/25/2020
• Initial Report FDA Received Date: 03/26/2020
• Supplement Report FDA Received Date: 04/09/2020; 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