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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: JOHNSON & JOHNSON SURGICAL VISION, INC. TECNIS TORIC II 1-PIECE ACRYLIC; TORIC IOLS
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JOHNSON & JOHNSON SURGICAL VISION, INC. TECNIS TORIC II 1-PIECE ACRYLIC; TORIC IOLS Back to Search Results
Model Number ZCU375
Health Effect - Clinical Code No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event Malfunction
Additional Manufacturer Narrative
Additional information: breakdown of 1 events is as follows: cosmetic issues, delivery issue 1 serial number of the suspect product: (b)(4).Zero investigations have been completed and 1 investigation is pending from this period.A review of the device history record, complaint trending, and risk documentation for this device will be performed.Upon completion of the review, if there is any further relevant information a supplemental medwatch will be filed.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.
 
Event or Problem Description
This report summarizes 1 malfunction events.The events were related to lens damage.There were no patient injuries reported associated to the events.
 
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Brand Name
TECNIS TORIC II 1-PIECE ACRYLIC
Common Device Name
TORIC IOLS
Manufacturer (Section D)
JOHNSON & JOHNSON SURGICAL VISION, INC.
1700 e st andrew place
santa ana CA 92705
MDR Report Key10767121
Report Number9614546-2020-00467
Device Sequence Number2908739
Product Code HQL
UDI-Device Identifier05050474700710
UDI-Public(01)05050474700710(17)241122
Combination Product (Y/N)Y
PMA/510(K) Number
P980040
Number of Events Summarized1
Summary Report (Y/N)Y
Reporter Type Manufacturer
Initial Reporter Occupation Other
Type of Report Initial
Report Date (Section B) 10/30/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Operator of Device No Information
Device Model NumberZCU375
Device Catalogue NumberZCU375U275
Type of Report(Section G)Periodic
Initial Date Received by Manufacturer Not provided
Initial Report FDA Received Date10/31/2020
Patient Sequence Number1
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