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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: JOHNSON & JOHNSON SURGICAL VISION, INC. EMERALD SURGICAL ADJUNCTS

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JOHNSON & JOHNSON SURGICAL VISION, INC. EMERALD SURGICAL ADJUNCTS Back to Search Results
Model Number EMERALDC30
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem No Code Available (3191)
Event Date 11/21/2018
Event Type  Injury  
Manufacturer Narrative
Age/date of birth: unknown/ not provided. Sex/gender: unknown/ not provided. Lot#: unknown/not provided. Expiration date: unknown as product lot number was not provided. Udi #: a complete udi # is unknown as product lot number was not provided. If implanted; give date: n/a (not applicable). The cartridge is not an implantable device. If explanted; give date: n/a (not applicable). The cartridge is not an implantable device; therefore, not explanted. (b)(6). Device manufacture date: unknown, as the lot number of the device was not provided. (b)(4). The cartridge is not returning for evaluation as it was discarded; therefore, a failure analysis of the complaint device cannot be completed. A review of the device history record, labeling, 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 Description
It was reported that tass (toxic anterior segment syndrome) was observed in two (2) patients 8 hours post implant of a model zcb00 tecnis monofocal iol (intraocular lens). The tass was significantly resolved on day 5. The customer indicated that all other conditions were the same, that the same consumable products were used in all six (6) cases performed, where no tass was observed on other cases on the day of surgery or the three (3) days prior. The customer suspect that either iol or the injector/cartridge could be the root cause for tass. In follow-up it was learned that the customer was not adequately cleaning the injector and this potential root cause was discussed with the customer. No additional information provided. This report pertains to one patient. A separate report is being submitted for the other patient.
 
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Brand NameEMERALD
Type of DeviceSURGICAL ADJUNCTS
Manufacturer (Section D)
JOHNSON & JOHNSON SURGICAL VISION, INC.
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
pamela mcclain
1700 east st. andrew place
santa ana, CA 92705
7142478243
MDR Report Key8197417
MDR Text Key131432102
Report Number2648035-2018-01657
Device Sequence Number1
Product Code KYB
Combination Product (y/n)Y
Reporter Country CodeIN
PMA/PMN Number
K961242
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation
Type of Report Initial,Followup
Report Date 01/01/2005,11/06/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/26/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model NumberEMERALDC30
Device Catalogue NumberEMERALDC30
Device Lot NumberUNKNOWN
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Date Report Sent to FDA01/01/2005
Event Location No Information
Date Report to Manufacturer01/10/2005
Date Manufacturer Received10/25/2020
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 Treatment Data
Date Received: 12/26/2018 Patient Sequence Number: 1
Treatment
ZCB00, SN: (B)(4). UNFOLDER/HANDPIECE, SN: UNKNOWN.
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