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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 Problem Break (1069)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 12/02/2021
Event Type  malfunction  
Manufacturer Narrative
Age, weight and ethnicity: unknown/not provided as patient identifiers were asked; however, none were provided.Unique identifier (udi) number: a partial udi was provided as the lot number was not provided.Expiration date: unknown as the lot number was not provided.If explanted; give date: not applicable as the handpiece is not an implantable device.If explanted; give date: not applicable as the handpiece is not an implantable device; therefore, device was not explanted.Phone number: (b)(6).Device manufacture date: unknown as the lot number was not provided.The device was not returned for analysis.No lot 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.Attempts have been made to obtain missing information; 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 that the plunger from emerald inserter created an indentation on the side/edge of the ar40m model intraocular lens (iol).The issue was observed post iol implantation.Account indicated that the incision was enlarged and the lens was removed/replaced during the same procedure.The emerald device is not available for evaluation.No further information provided.This is report 1 of 2.
 
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Brand Name
UNFOLDER EMERALD
Type of Device
LENS, GUIDE, INTRAOCULAR
Manufacturer (Section D)
JOHNSON & JOHNSON SURGICAL VISION, INC.
31 technology drive
irvine CA 92618
Manufacturer Contact
somyata nagpal
31 technology drive
irvine, CA 92618
7142478552
MDR Report Key13359430
MDR Text Key289461040
Report Number3012236936-2022-00221
Device Sequence Number1
Product Code KYB
UDI-Public(01)(10)UNKNOWN
Combination Product (y/n)N
Reporter Country CodeCA
PMA/PMN Number
K961242
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Health Professional,User Facility,Company Representative
Reporter Occupation Non-Healthcare Professional
Type of Report Initial
Report Date 01/26/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/26/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model NumberEMERALDXL
Device Catalogue NumberEMERALDXL
Device Lot NumberUNKNOWN
Was Device Available for Evaluation? No
Was the Report Sent to FDA? No
Date Manufacturer Received01/03/2022
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 Sequence Number1
Treatment
LENS AR40M,SN:(B)(4).
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