MAUDE Adverse Event Report: BAUSCH & LOMB ENVISTA TORIC IOL; LENS, INTRAOCULAR TORIC OPTICS

Model Number MX60T

Device Problems Leak/Splash (1354); Packaging Problem (3007)

Patient Problem No Patient Involvement (2645)

Event Type  malfunction  

Event Description

It was reported that there was no fluid in the lens vial and it was scratched.There was no patient contact.This was discovered during preparation for use.

Manufacturer Narrative

Investigation of this event is in progress.A supplemental report will be submitted upon completion of the investigation.Note: envista toric is not currently approved for marketing in the united states.This report is being submitted based on similarity with envista intraocular lens.

• Brand Name: ENVISTA TORIC IOL
• Type of Device: LENS, INTRAOCULAR TORIC OPTICS
• Manufacturer (Section D): BAUSCH & LOMB; rochester NY
• Manufacturer (Section G): BAUSCH & LOMB; 21 n park place blvd; clearwater FL 33759
• Manufacturer Contact: sharon spencer ; 50 technology drive; irvine, CA 92618 ; 9493985698
• MDR Report Key: 4680458
• MDR Text Key: 5624008
• Report Number: 1313525-2015-00728
• Device Sequence Number: 1
• Product Code: MJP
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: P910056
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,User Facility,Company Representative
• Reporter Occupation: Not Applicable
• Type of Report: Initial
• Report Date: 03/11/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/08/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/29/2016
• Device Model Number: MX60T
• Device Lot Number: 3345141
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 03/11/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1