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

Model Number	PCB00
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	03/20/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
If implanted, give date: not applicable, the lens was removed/replaced within the initial procedure.If explanted, give date: not applicable, the lens was removed/replaced within the initial procedure.(b)(4).All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.
Event or Problem Description
It was reported that a pcb00 15.5 diopter intraocular lens (iol) was removed and replaced with another lens during the same procedure due to a broken haptic.Incision was enlarged, but no harm or injury to the patient.Reportedly, patient has recovered.No further information was provided.
Additional Manufacturer Narrative
Device available for evaluation; device returned to manufacturer on august 8, 2019.Device evaluation: the pcb00 insertion device was received on 08/08/2019.The plunger was observed in the advanced position.The pcb00 device was observed under microscope and a scarce amount of viscoelastic was observed in the cartridge.The directions for use (dfu) states to completely fill the viewing window of the pcb00 with ophthalmic viscosurgical device (ovd).The lens was observed cut in half with a haptic detached.The condition observed is consistent with a lens that has been explanted.The reported issue was not verified.The cut lens and detached haptic was confirmed; but, could not be determined whether it was related to manufacturing process as the reported lens was used and cut during a surgical procedure.Manufacturing record review: the units were released according specification in compliance with the product intended use as required.A search on complaints revealed that two other complaints were identified under this production order; however, were not related to this complaint.Based on the results of the investigation, no product deficiency was identified.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 (b)(4) and capa(b)(4).

• 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: 8844419
• Report Number: 2648035-2019-00818
• Device Sequence Number: 16781183
• Product Code: HQL
• UDI-Device Identifier: 05050474558175
• UDI-Public: (01)05050474558175(17)211219
• Combination Product (Y/N): Y
• Initial Reporter State: WI
• Initial Reporter Country: US
• PMA/510(K) Number: P980040
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,health profession
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 11/11/2020
• 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?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 12/19/2021
• Device Model Number: PCB00
• Device Catalogue Number: PCB0000155
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/08/2019
• Was the Report Sent to FDA?: No
• Date Report to Manufacturer: 01/10/2005
• Initial Date Received by Manufacturer: 07/01/2019
• Supplement Date Received by Manufacturer: 08/16/2019; 10/25/2020
• Initial Report FDA Received Date: 07/31/2019
• Supplement Report FDA Received Date: 09/10/2019; 11/12/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 77 YR
• Date Report Sent to FDA: 01/01/2005