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

Model Number	PCB00
Medical Device Problem Codes	Difficult or Delayed Positioning (1157); Positioning Failure (1158)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	04/10/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The lens was not implanted.Device evaluation: the product was returned to the manufacturing site for evaluation.Visual inspection using microscope magnification showed the plunger and pushrod in advanced positions.Lack of viscoelastic material was observed on cartridge.Dent/distortion was observed at the cartridge tip section.Lens was also observed damaged and stuck in cartridge.No assembly error and/or defect were observed in the preloaded device related to manufacturing process.The condition in which the sample returned is consistent with a product that was handled and prepared for a surgical process.The complaint issue reported as uncontrolled delivery could not be verified.Manufacturing records review: the manufacturing records for the intraocular lens were reviewed.The product was manufactured and released according to specification.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 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
A pre-loaded iol was evaluated and found there was dent/distortion observed at the cartridge tip section.Lens was also observed damaged and stuck in cartridge.Initially, it was reported that a pcb00 3.5 diopter lens shot out of the insertion system before entering the patient''s operative eye.Reportedly, there was no patient contact, and this occurred during handling and prior to insertion.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 (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.; santa ana CA
• MDR Report Key: 7759943
• Report Number: 2648035-2018-01096
• Device Sequence Number: 1705492
• Product Code: HQL
• UDI-Device Identifier: 05050474558137
• UDI-Public: (01)05050474558137(17)200114
• Combination Product (Y/N): Y
• Initial Reporter State: OH
• 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
• Report Date (Section B): 10/29/2020
• 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: 01/14/2020
• Device Model Number: PCB00
• Device Catalogue Number: PCB0000135
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/13/2018
• Was the Report Sent to FDA?: No
• Date Report to Manufacturer: 01/10/2005
• Initial Date Received by Manufacturer: 08/06/2018
• Supplement Date Received by Manufacturer: 10/25/2020
• Initial Report FDA Received Date: 08/07/2018
• Supplement Report FDA Received Date: 10/29/2020
• 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