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U.S. Department of Health and Human Services

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

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JOHNSON & JOHNSON SURGICAL VISION, INC. TECNIS 1-PIECE; MONOFOCAL IOLS Back to Search Results
Model Number ZCB00
Device Problem Contamination (1120)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Type  malfunction  
Manufacturer Narrative
Date of event: unknown as information was not provided.Catalog number: a complete catalog number is unknown, as product serial number was not provided.Expiration date: unknown as product serial number was not provided.Device serial number: unknown as information was not provided.Udi number: a complete udi number is unknown as product serial number was not provided.If implanted: unknown as information was not provided.If explanted: not applicable as the iol remains implanted.A failure analysis of the complaint device cannot be completed as product remains implanted.Also, because we do not have product identifiers device history record and trending cannot be performed.If there is any further relevant information received a supplemental medwatch will be filed.Device manufacture date: unknown, as product serial number was not provided.Attempts were made to contact the customer account requesting additional information regarding complaint however, to date no response has been received.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.
 
Event Description
It was reported an unknown quantity of intraocular lenses (iols) have had a thin film of debris in the middle of the iol that is stuck on the posterior side.Film is removeable with irrigation/aspiration (i/a) and extra polishing time behind the lens at the end of the case.Doctor is concerned this is not normal and the possibility of the issue becoming visually significant.No further information was provided.
 
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Brand Name
TECNIS 1-PIECE
Type of Device
MONOFOCAL IOLS
Manufacturer (Section D)
JOHNSON & JOHNSON SURGICAL VISION, INC.
1700 e. st. andrew place
santa ana CA 92705
Manufacturer (Section G)
JOHNSON & JOHNSON SURGICAL VISION, INC.
road 402 north, km 4.2
anasco industrial park
anasco PR 00610
Manufacturer Contact
somyata nagpal
1700 east st. andrew place
santa ana, CA 92705
7142478200
MDR Report Key10776255
MDR Text Key214800177
Report Number2648035-2020-00809
Device Sequence Number1
Product Code HQL
UDI-Public(01)
Combination Product (y/n)Y
Reporter Country CodeUS
PMA/PMN Number
P980040
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Reporter Occupation Physician
Type of Report Initial
Report Date 11/02/2020
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
Device Operator Health Professional
Device Model NumberZCB00
Device Catalogue NumberZCB00
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 10/06/2020
Initial Date FDA Received11/02/2020
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 Number1
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