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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 ZCU150
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Vitrectomy (2643); No Code Available (3191)
Event Date 12/02/2019
Event Type  Injury  
Manufacturer Narrative
If implanted, give date: unknown/not provided.If explanted, give date: unknown/not provided.(b)(4).Device evaluation: the product testing could not be performed as the product was not returned.The reported complaint could not be verified.Manufacturing record review: the manufacturing records for the product were reviewed.The product was manufactured and released according to specifications.A search revealed that no similar complaints were received for this production order.Conclusion: as a result of the investigation there is no indication of a product quality deficiency and the reported issue could not be verified.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.
 
Event Description
Was reported that a zxr00 20.0 diopter intraocular lens was explanted from the patient¿s right eye due to myopia.The patient is not bothered by any dysphotopsia and loves her first eye surgery with a the symfony lens, but the eye turned out plano so the doctor attempted to improve her near vision by implanting a piggy back lens.This resulted in the patient being too myopic.Therefore, the doctor decided to explant the iol and replaced it with the same model but a lower diopter 19.0.A vitrectomy was required.Thru follow-up the customer also explained that the patient¿s capsule did not tear, patient had a 1-2 clock hour zonluar dialysis with a few vitreous strands entering the anterior chamber that required a limited anterior vitrectomy.The lens was perfectly stable and on axis.Further follow-up was conducted but the customer did not have any more information regarding this issue.Reportedly, the patient is doing well.No further information was provided.
 
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 (b)(4) 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 Key9532341
MDR Text Key182571701
Report Number9614546-2019-01137
Device Sequence Number1
Product Code HQL
UDI-Device Identifier05050474657793
UDI-Public(01)05050474657793(17)240827
Combination Product (y/n)Y
PMA/PMN Number
P980040
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional,user faci
Type of Report Initial,Followup
Report Date 01/01/2005,11/04/2020
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? No
Device Operator Health Professional
Device Expiration Date08/27/2024
Device Model NumberZCU150
Device Catalogue NumberZCU150U200
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 12/03/2019
Initial Date FDA Received12/30/2019
Supplement Dates Manufacturer Received10/25/2020
Supplement Dates FDA Received11/04/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
Patient Age54 YR
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