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

Model Number	PCB00
Medical Device Problem Codes	Material Split, Cut or Torn (4008); Failure to Eject (4010)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	12/13/2018
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.Device evaluation: the preloaded delivery system was returned at the manufacturing site for evaluation.Visual inspection using magnification showed residue of viscoelastic material on the cartridge.The plunger and push-rod were observed in advanced position.The intraocular lens (iol) was not in the cartridge.No lens was returned.The cartridge tip was observed cracked.No assembly error and/or defect were observed in the preloaded device related to manufacturing process.The customer's reported complaint could not be verified.The condition of the returned sample was consistent with a product that was handled and prepared for a surgical process.There was no evidence to suggest that the complaint sample was affected by the manufacturing process.No product deficiency was identified.Manufacturing record review: manufacturing record review of the production order and related document revealed that the product was manufactured and released according to specifications.A search revealed that no additional complaints for this order number have been received.Labeling review: the labeling review was completed.The directions for use (dfu) adequately provide 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 and the reported issue could not be verified.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.
Event or Problem Description
It was reported that the cartridge of the preloaded delivery system (model pcb00) was split during implantation of the intraocular lens (iol) into the patient's operative eye.There was patient contact but no injury occurred.Additional information was received and it was learnt that the lens was stuck in the cartridge and it was partially delivered into the eye.There was no incision enlargement, no vitrectomy was performed and no sutures used.No other 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 (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.; 1700 e st andrew place; santa ana CA 92705
• MDR Report Key: 8354410
• Report Number: 2648035-2019-00211
• Device Sequence Number: 2120300
• Product Code: HQL
• UDI-Device Identifier: 05050474558182
• UDI-Public: (01)05050474558182(17)211105
• Combination Product (Y/N): Y
• Initial Reporter State: AL
• 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: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 11/09/2020
• 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: 11/05/2021
• Device Model Number: PCB00
• Device Catalogue Number: PCB0000160
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/18/2019
• Was the Report Sent to FDA?: No
• Date Report to Manufacturer: 01/10/2005
• Initial Date Received by Manufacturer: 01/24/2019
• Supplement Date Received by Manufacturer: 10/25/2020
• Initial Report FDA Received Date: 02/20/2019
• Supplement Report FDA Received Date: 11/10/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 47 YR
• Date Report Sent to FDA: 01/01/2005