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

Model Number PCB00

Device Problem Sharp Edges (4013)

Patient Problem Capsular Bag Tear (2639)

Event Type  Injury  

Manufacturer Narrative

Date of birth: unknown as information was not provided.Gender: unknown as information was not provided.Date of event: unknown as information was not provided.Catalog #: a complete catalog number is unknown, as product serial number was not provided.Expiration date: unknown as product serial number was not provided.Serial #: unknown as information was not provided.Udi # is unknown as product serial number was not provided.If implanted; give date: unknown as information was not provided.If explanted; give date: unknown as information was not provided.Device manufacture date: unknown, as product serial number was not provided.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.

Event Description

It was reported a pcb00 intraocular lens (iol) tore the posterior capsule during insertion, this happened in two cases.It was reported a sharp edge of the folded iol created a tear in the posterior capsule.When the account executive attempted to gather further information, the surgeon mentioned it happened last year and he did not recall the patients.The doctor said the incidents did not interfere with the surgeries and he was not able to provide any further information.Attempts were made to contact the customer account requesting additional information however, to date no response has been received.This report captures the 2nd pcb00 lens.No additional information was provided to johnson & johnson surgical vision.

Manufacturer Narrative

Device evaluation: product testing could not be performed because the product was not returned.A product quality deficiency could not be confirmed.The reported issue was not verified.Manufacturing records review: the manufacturing record cannot be reviewed since the iol serial number is unknown.Historical data analysis: the complaint history was not reviewed since the iol serial number is unknown.Labeling review: the directions for use (dfu) were reviewed, the dfu adequately provides instructions and precautions along with warnings for the proper use and handling of the device.Conclusion: as a result, of the investigation there is no indication of a product malfunction or product quality deficiency.The reported issue was not verified.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 (b)(4) and capa-010215.

• 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: 8476907
• MDR Text Key: 140735192
• Report Number: 2648035-2019-00416
• Device Sequence Number: 1
• Product Code: HQL
• UDI-Public: (01)
• 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: 01/01/2005,11/11/2020

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 Model Number: PCB00
• Device Catalogue Number: PCB00
• Was Device Available for Evaluation?: No
• 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: 03/06/2019
• Initial Date FDA Received: 04/03/2019
• Supplement Dates Manufacturer Received: 04/10/2019; 10/25/2020
• Supplement Dates FDA Received: 04/15/2019; 11/12/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other