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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 ZCU600
Device Problem Unintended Movement (3026)
Patient Problems Blurred Vision (2137); Visual Impairment (2138)
Event Date 02/03/2020
Event Type  Injury  
Manufacturer Narrative
Date of event: exact date unknown/not provided.Best estimate date is between (b)(6) 2020.If explanted; give date: not applicable, there is no indication the lens has been explanted.An attempt has been made to obtain missing information; however, no definitive response has been received.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.
 
Event Description
It was reported that the patient is experiencing blurred vision with model zcu600 intraocular lens (iol) and the lens rotated 35 degrees counter clockwise in the right eye.Visual acuity pre-operative 20/40 and visual acuity post-op 20/400.The lens was planned for an explant.No additional information was provided to johnson & johnson surgical vision.
 
Manufacturer Narrative
Additional information: further information was provided and the lens was explanted as planned.The reason for explant was reported as likely due to miscalculation.The lens was replaced with the same model zcu600 10.5 (lower) diopter.No additional information was provided.The following section has been updated accordingly: section d7: if explanted; give date: (b)(6) 2020.Device evaluation: the device was not returned at the manufacturing site; therefore; product testing could not be performed, and the customer¿s reported complaint could not be verified.Manufacturing record review: the manufacturing records for the intraocular lens were reviewed.The product was manufactured according to specifications.The search revealed that no similar complaint for this production order number has been received.Conclusion: as a result of the investigation there is no indication of a product quality deficiency.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.
 
Manufacturer Narrative
This correction mdr is being submitted to address inaccurate information in section f on the xml version of the previous submission caused by a software glitch in the transmission process.The internal non-conformance numbers for this software issue are nr-0148919 and capa-010215.
 
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Brand Name
TECNIS TORIC II 1-PIECE ACRYLIC
Type of Device
TORIC IOLS
Manufacturer (Section D)
JOHNSON & JOHNSON SURGICAL VISION, INC.
1700 e st andrew place
santa ana CA 92705
MDR Report Key9795835
MDR Text Key188271216
Report Number9614546-2020-00107
Device Sequence Number1
Product Code HQL
UDI-Device Identifier05050474665323
UDI-Public(01)05050474665323(17)241205
Combination Product (y/n)Y
PMA/PMN Number
P980040
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Type of Report Initial,Followup,Followup
Report Date 01/01/2005,11/02/2020
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? Yes
Device Operator Health Professional
Device Model NumberZCU600
Device Catalogue NumberZCU600U130
Was Device Available for Evaluation? No
Was the Report Sent to FDA? No
Date Report Sent to FDA01/01/2005
Date Report to Manufacturer01/10/2005
Initial Date Manufacturer Received 02/07/2020
Initial Date FDA Received03/05/2020
Supplement Dates Manufacturer Received03/23/2020
10/25/2020
Supplement Dates FDA Received04/16/2020
11/02/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Other;
Patient Age58 YR
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