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U.S. Department of Health and Human Services

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

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AMO PUERTO RICO MFG. INC. UNFOLDER EMERALD LENS, GUIDE, INTRAOCULAR Back to Search Results
Model Number EMERALDC30
Device Problems Contamination (1120); Scratched Material (3020)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Type  malfunction  
Manufacturer Narrative
Per eu regulation 2016/679 (general data protection regulation), patient identifiers were not collected or recorded and therefore are not available. Date of event: unknown/no information. 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; therefore, not explanted. (b)(6). The device has not returned 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.
 
Event Description
It was reported that an intraocular lens (iol) implanted in a 45-year-old female patient's eye was "extremely scratched". Further follow-ups revealed that the cartridge caused the scratches during the loading process while preparing the lens for implantation. No further information was provided.
 
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Brand NameUNFOLDER 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 Key13510422
MDR Text Key296305986
Report Number3012236936-2022-00340
Device Sequence Number1
Product Code KYB
Combination Product (y/n)N
Reporter Country CodeGM
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,Followup
Report Date 04/07/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/10/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date07/27/2022
Device Model NumberEMERALDC30
Device Catalogue NumberEMERALDC30
Device Lot NumberCJ26367
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Date Manufacturer Received03/30/2022
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured07/27/2021
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: 02/10/2022 Patient Sequence Number: 1
Treatment
AR40E LENS, LOT UNKNOWN
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