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U.S. Department of Health and Human Services

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

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AMO PUERTO RICO MFG. INC. UNK_CARTRIDGE_EMERALD LENS, GUIDE, INTRAOCULAR Back to Search Results
Model Number EMERALDC30
Device Problems Contamination (1120); Crack (1135)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 12/07/2021
Event Type  malfunction  
Event Description
It was reported that the cartridge cracked and debris was found in the eye. It was removed and no impact or adverse event to patient. No further information was available.
 
Manufacturer Narrative
(b)(6). It was indicated that the device is not returning for evaluation; therefore, a failure analysis of the complaint device cannot be completed. A review of the device history record, 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. 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.
 
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Brand NameUNK_CARTRIDGE_EMERALD
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
31 technology drive
irvine, CA 92618
7142478552
MDR Report Key13177297
MDR Text Key290376670
Report Number3012236936-2022-00056
Device Sequence Number1
Product Code KYB
Combination Product (y/n)N
Reporter Country CodeCH
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
Type of Report Initial,Followup
Report Date 04/04/2022
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received01/06/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberEMERALDC30
Device Catalogue NumberEMERALDC30
Device Lot NumberUNKNOWN
Was Device Available for Evaluation? Device Returned to Manufacturer
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Date Manufacturer Received03/08/2022
Was Device Evaluated by Manufacturer? Yes
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No

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