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

Model Number PCB00

Device Problems Material Separation (1562); Detachment of Device or Device Component (2907); Appropriate Term/Code Not Available (3191)

Patient Problem No Code Available (3191)

Event Type  Injury  

Manufacturer Narrative

Date of event: the exact date of event is unknown.The best estimate is a week prior to (b)(6) 2018.The intraocular lens was removed and replaced during the same procedure.(b)(4).Device evaluation: product testing could not be performed as the product was not returned.The reported complaint cannot be confirmed.Manufacturing records review: the manufacturing records for the device were reviewed.The product was manufactured and released according to specification.A search on complaints was conducted and revealed that one (1) additional complaint was received from this production order number, but is not related to this event, and no product quality deficiency was identified.Labeling review: the directions for use (dfu) was reviewed.The dfu adequately provides 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.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.

Event Description

It was reported that two pcb00 intraocular lenses were inserted and removed from the same patient¿s operative eye during same procedure, one after the other.Both lenses were cut out of the eye and both lenses were reported with loading issues and both with a missing/detached haptic.The first lens was inserted and found to have a chunk of optic and haptic was missing, also noted it was folded funny and the customer was unsure if haptic came out first or not.This lens was cut and pulled out of the wound.A second pcb00 lens was then inserted.This second lens was also cut out of the eye after a haptic was found floating in the anterior chamber.The procedure was completed using a non-johnson and johnson iol.There was an incision enlargement required but no vitrectomy.No additional information was provided to johnson & johnson surgical vision.This report pertains to the pcb00 24.0 diopter intraocular lens (iol).A separate report is being submitted for the pcb00 23.5 diopter intraocular lens (iol).

Manufacturer Narrative

Additional information: device available for evaluation: yes.Returned to manufacturer on: 01/09/2019.Device returned to manufacturer: yes.Device evaluation: returned pcb00 device was received inside the original box (folding carton).The plunger was observed in fully advanced position.The pcb00 device was observed under microscope and traces of viscoelastic and/or balanced salt solution were observed in the cartridge.Dfu states to completely fill the viewing window of the pcb00 with ovd.The folded lens was observed stuck and overridden in the cartridge tube zone.There were no damages observed on the assembly, neither flashes there is no visible gap.The device pcb00 was disarmed, as part of the evaluation.A piece of lens with one haptic (incomplete) was observed.The reported complaint issue haptic detached was verified.Lead haptic and stuck inserter issue were not confirmed.Based on the analysis of returned product there is no indication of product quality deficiency.Manufacturing records review: during the manufacturing record review of the production order for this serial number, no product deficiency was identified.The documentation shows that the production order was manufactured and released according to specifications.Labeling review: the labeling review was completed and revealed that the directions for use (dfu) provide the customer with proper usage instructions and guidelines.Conclusion: as a result, of the investigation there is no indication of a product malfunction or product quality deficiency.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.

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-(b)(4) and capa-(b)(4).

• Brand Name: TECNIS ITEC PRELOADED 1-PIECE IOL
• Type of Device: MONOFOCAL IOLS
• Manufacturer (Section D): JOHNSON & JOHNSON SURGICAL VISION, INC.; 1700 e. st. andrew place; santa ana CA 92705
• MDR Report Key: 8205706
• MDR Text Key: 131701755
• Report Number: 2648035-2018-01680
• Device Sequence Number: 1
• Product Code: HQL
• UDI-Device Identifier: 05050474558342
• UDI-Public: (01)05050474558342(17)200214
• Combination Product (y/n): Y
• PMA/PMN Number: P980040
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup,Followup
• Report Date: 01/01/2005,11/05/2020

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
• Device Operator: Health Professional
• Device Expiration Date: 02/14/2020
• Device Model Number: PCB00
• Device Catalogue Number: PCB0000240
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/09/2019
• Was the Report Sent to FDA?: No
• Date Report Sent to FDA: 01/01/2005
• Date Report to Manufacturer: 01/10/2005
• Initial Date Manufacturer Received: 10/18/2018
• Initial Date FDA Received: 12/31/2018
• Supplement Dates Manufacturer Received: 01/02/2019; 10/25/2020
• Supplement Dates FDA Received: 01/24/2019; 11/05/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention