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	Failure to Unfold or Unwrap (1669); Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	10/15/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
If explanted, give date: not applicable, as lens remains implanted.81: it was indicated that the device is not returning for evaluation as the lens remains implanted; therefore a failure analysis of the complaint device cannot be completed.A review of the device/lot history record, labeling, complaint trending, and risk documentation for this device will be performed.Upon completion of the review, if there is any further relevant information a supplemental medwatch will be filed.All pertinent information available to (b)(6) has been submitted.
Event or Problem Description
It was reported that a pcb00 intraocular lens (iol) haptic tips stuck together to the interior part of the iol.It required the surgeon to enter the eye two or three times more with extra instruments to try to un-pry the haptics which he ultimately did.There was no patient injury or suture or incision enlargement.It was stated that the patient outcome was good but the customer needed to report the event as directions for use (dfu) was followed perfectly yet haptics still stuck together and it took a while for the surgeon to unstick the haptics.Further follow-up confirmed that with this product, the complaint of sticking haptics wasn¿t noticed until the product was in the eye.Since the implanted iol wasn¿t damaged, the customer decided to use it.There was no backup iol needed.It was noted that the patient is a (b)(6) year old, female.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 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.; 1700 east st. andrew place; santa ana CA 92705
• MDR Report Key: 8049622
• Report Number: 2648035-2018-01446
• Device Sequence Number: 1787126
• Product Code: HQL
• UDI-Device Identifier: 05050474558175
• UDI-Public: (01)05050474558175(17)210727
• Combination Product (Y/N): Y
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: P980040
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 11/04/2020
• 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: 07/27/2021
• Device Model Number: PCB00
• Device Catalogue Number: PCB0000155
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Report to Manufacturer: 01/10/2005
• Initial Date Received by Manufacturer: 10/15/2018
• Supplement Date Received by Manufacturer: 10/25/2020
• Initial Report FDA Received Date: 11/07/2018
• Supplement Report FDA Received Date: 11/04/2020
• 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
• Date Report Sent to FDA: 01/01/2005