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)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
If implanted; give date: n/a (not applicable).The intraocular lens was not implanted.If explanted; give date: n/a (not applicable).The intraocular lens was not implanted.(b)(6).All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.
Event or Problem Description
It was reported that during the implantation of the intraocular lens (iol), the surgeon began to screw the plunger of the preloaded delivery system (model pcb00), but the lens did not come out of the cartridge.Reportedly, there was patient contact with both the cartridge tip and the lens.Another lens was used instead.There was no patient injury and there was no incision enlargement.No additional information was provided.
Additional Manufacturer Narrative
Device available for evaluation: yes.Returned to manufacturer on: 01/08/2019.Device returned to manufacturer: yes.Device evaluation: the pcb00 preloaded system was received at manufacturing site.The plunger push rod component was observed in a fully advanced position.The cartridge component was observed correctly engaged into lower body of the pcb00 unit.Visual inspection using magnification was performed.The lens was observed stuck at the cartridge loading zone.The push rod tip overrides the lens.The reported issue was verified.However, there is no evidence to suggest that the complaint sample has been affected by the manufacturing process.No product deficiency was identified.Manufacturing records review: the manufacturing records for the product was reviewed.The product was manufactured and released according to specification.A search on complaints revealed that no additional complaint was received for this production order.Labeling review: 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.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 & JOHNSON SURGICAL VISION, INC.; santa ana CA 92705
• MDR Report Key: 8151154
• Report Number: 2648035-2018-01607
• Device Sequence Number: 295196
• Product Code: HQL
• UDI-Device Identifier: 05050474558205
• UDI-Public: (01)05050474558205(17)210524
• Combination Product (Y/N): Y
• Initial Reporter Country: NL
• 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): 11/05/2020
• 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: 05/24/2021
• Device Model Number: PCB00
• Device Catalogue Number: PCB0000170
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/08/2019
• Was the Report Sent to FDA?: No
• Date Report to Manufacturer: 01/10/2005
• Initial Date Received by Manufacturer: 11/21/2018
• Supplement Date Received by Manufacturer: 02/01/2019; 10/25/2020
• Initial Report FDA Received Date: 12/11/2018
• Supplement Report FDA Received Date: 02/27/2019; 11/05/2020
• 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