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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: AMO PUERTO RICO MFG. INC. EMERALD CARTRIDGE LENS, GUIDE, INTRAOCULAR

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AMO PUERTO RICO MFG. INC. EMERALD CARTRIDGE LENS, GUIDE, INTRAOCULAR Back to Search Results
Model Number EMERALDC30
Device Problems Material Fragmentation (1261); Device Difficult to Setup or Prepare (1487); Material Split, Cut or Torn (4008)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 06/17/2021
Event Type  malfunction  
Manufacturer Narrative
Pt info: unknown/ not provided. If implanted, give date: not applicable, the cartridge is not an implantable device. If explanted, give date: not applicable, the cartridge is not an implantable device. Telephone number: (b)(6). All pertinent information available to johnson & johnson surgical vision, inc has been submitted.
 
Event Description
Customer reported that during the handling of the emerald cartridge, inserting methylcellulose and position the intraocular lens (iol), the cartridge was presenting rigidity while the iol was being inserted in the eye. Resulting in a torn optical part and the haptic was completely amputated. There was no reported patient impact. No additional information provided.
 
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Brand NameEMERALD CARTRIDGE
Type of DeviceLENS, GUIDE, INTRAOCULAR
Manufacturer (Section D)
AMO PUERTO RICO MFG. INC.
road 402 north, anasco ind. pk
anasco PR 00610
Manufacturer Contact
somyata nagpal
road 402 north, anasco ind. pk
anasco, PR 00610
7142478552
MDR Report Key12200785
MDR Text Key262699222
Report Number2648035-2021-08182
Device Sequence Number1
Product Code KYB
Combination Product (y/n)N
Reporter Country CodeBR
PMA/PMN Number
K961242
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,health professional,u
Reporter Occupation Nurse Practitioner
Type of Report Initial,Followup
Report Date 10/26/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/21/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date03/01/2022
Device Model NumberEMERALDC30
Device Catalogue NumberEMERALDC30
Device Lot NumberCJ15429
Was Device Available for Evaluation? No
Is the Reporter a Health Professional?
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received10/12/2021
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured03/01/2021
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: 07/21/2021 Patient Sequence Number: 1
Treatment
IOL SERIAL# AND MODEL UNKNOWN
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