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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: JOHNSON & JOHNSON SURGICAL VISION, INC. UNFOLDER EMERALD LENS, GUIDE, INTRAOCULAR

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JOHNSON & JOHNSON SURGICAL VISION, INC. UNFOLDER EMERALD LENS, GUIDE, INTRAOCULAR Back to Search Results
Model Number EMERALDXL
Device Problems Break (1069); Use of Device Problem (1670); Inaccurate Delivery (2339)
Patient Problem Capsular Bag Tear (2639)
Event Date 06/10/2021
Event Type  Injury  
Manufacturer Narrative
Patient information: unknown/no information. Unique identifier (udi) number: a partial udi was provided as the serial number was not provided. Expiration date: unknown as the serial number was not provided. If explanted; give date: not applicable as the hand piece is not an implantable device. If explanted; give date: not applicable as the hand piece is not an explantable device manufacture date: unknown as the serial number was not provided. The device was not returned for analysis. No serial number was provided for this device; therefore, no further investigation can be performed. If there is any further relevant information received, a supplemental medwatch will be filed. All pertinent information available to johnson & johnson surgical vision, inc. Has been submitted. Attempts have been made to obtain missing information; however, to date, no response has been received.
 
Event Description
It was initially reported that the lens injector wasn't working properly. Through follow-up additional information was provided explaining that the injector was broken/bent. The issue was noticed while trying to advance the lens through the injector. The injector was initially stuck and then the intraocular lens (iol) shot into the eye. The customer further explained that the lens fired into the vitreous cavity and had to be removed. Additionally, the surgeon stated the issue was not the lens, but a maintenance issue of the surgical equipment by staff. The injectors were supposed to be sent in for repair. He does not see a problem with johnson & johnson product. The patient is reported to be fine now. No further information was provided.
 
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Brand NameUNFOLDER EMERALD
Type of DeviceLENS, GUIDE, INTRAOCULAR
Manufacturer (Section D)
JOHNSON & JOHNSON SURGICAL VISION, INC.
1700 e st andrew place
santa ana CA 92705
Manufacturer Contact
somyata nagpal
1700 e st andrew place
santa ana, CA 92705
7142478552
MDR Report Key12284809
MDR Text Key265367188
Report Number2020664-2021-07076
Device Sequence Number1
Product Code KYB
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K961242
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Reporter Occupation
Type of Report Initial
Report Date 08/05/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/05/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberEMERALDXL
Device Catalogue NumberEMERALDXL
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received07/06/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse

Patient Treatment Data
Date Received: 08/05/2021 Patient Sequence Number: 1
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