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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ABBOTT MEDICAL OPTICS TECNIS; TORIC IOLS
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ABBOTT MEDICAL OPTICS TECNIS; TORIC IOLS Back to Search Results
Model Number ZCT150
Medical Device Problem Code Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code No Code Available (3191)
Date of Event 06/12/2017
Type of Reportable Event Serious Injury
Additional Manufacturer Narrative
(b)(4).All pertinent information available to abbott medical optics has been submitted.
 
Event or Problem Description
It was reported that a tecnis model zct150 intraocular lens (iol) was explanted from a female patient's eye because she decided she wanted a symfony lens.Nothing was wrong with the zct150 lens.A zxt150 11.0 diopter iol was implanted and the patient is doing fine.
 
Additional Manufacturer Narrative
Correction: upon further review of this file it was determined that the initial medwatch report was filed in error as it is a duplicate of report 9614546-2017-00596.No further information will be submitted under this medwatch number.
 
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Brand Name
TECNIS
Common Device Name
TORIC IOLS
Manufacturer (Section D)
ABBOTT MEDICAL OPTICS
santa ana CA
MDR Report Key6699520
Report Number9614546-2017-00602
Device Sequence Number10777409
Product Code HQL
UDI-Device Identifier05050474551978
UDI-Public(01)05050474551978(17)190805
Combination Product (Y/N)N
Initial Reporter StatePA
Initial Reporter CountryUS
PMA/510(K) Number
P980040
Number of Events Summarized1
Summary Report (Y/N)N
Device Explanted Year2017
Reporter Type Manufacturer
Report Source health professional,user faci
Initial Reporter Occupation Other
Type of Report Initial,Followup
Report Date (Section B) 08/04/2017
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? No
Operator of Device Physician
Device Expiration Date08/05/2019
Device Model NumberZCT150
Device Catalogue NumberZCT150U115
Was Device Available for Evaluation? No
Initial Date Received by Manufacturer 06/15/2017
Supplement Date Received by Manufacturer07/11/2017
Initial Report FDA Received Date07/10/2017
Supplement Report FDA Received Date08/04/2017
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
Outcome Attributed to Adverse Event Required Intervention;
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