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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BAUSCH + LOMB ENVISTA TORIC INTRAOCULAR LENS LENS, INTRAOCULAR, TORIC OPTICS

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BAUSCH + LOMB ENVISTA TORIC INTRAOCULAR LENS LENS, INTRAOCULAR, TORIC OPTICS Back to Search Results
Model Number MXUT
Device Problem Difficult or Delayed Positioning
Event Date 11/13/2018
Event Type  Injury  
Manufacturer Narrative

Investigation of this event is in progress. A follow-up report will be submitted upon completion of the investigation.

 
Event Description

It was reported that the surgeon re-positioned the lens post-procedure and also placed a capsular tension ring. Additional information has been requested, but has not been received.

 
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Brand NameENVISTA TORIC INTRAOCULAR LENS
Type of DeviceLENS, INTRAOCULAR, TORIC OPTICS
Manufacturer (Section D)
BAUSCH + LOMB
1400 north goodman street
rochester NY 14609
Manufacturer (Section G)
BAUSCH + LOMB
21 north park place blvd.
clearwater FL 33759
Manufacturer Contact
tes proud
1400 north goodman street
rochester , NY 14609
5853388549
MDR Report Key8158369
Report Number0001313525-2018-00234
Device Sequence Number1
Product CodeMJP
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE
Reporter Occupation
Type of Report Initial,Followup,Followup
Report Date 11/16/2018
2 DeviceS WERE Involved in the Event: 1   2  
1 Patient Was Involved in the Event
Date FDA Received12/12/2018
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator HEALTH PROFESSIONAL
Device MODEL NumberMXUT
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Is this a Reprocessed and Reused Single-Use Device? No

Patient TREATMENT DATA
Date Received: 12/12/2018 Patient Sequence Number: 1
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