• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

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

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

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
Age, weight, ethnicity: information unknown/not provided. 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/not provided. If implanted, give date: n/a (not applicable). The cartridge is not an implantable device. If explanted, give date: n/a (not applicable). The cartridge is not an implantable device; therefore, not explanted. Phone number: (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 all pertinent information available to johnson & johnson surgical vision, inc. Has been submitted.
 
Event Description
It was reported that there were scratch marks on the intraocular lenses (iols) after implantation. The issues were first identified during the follow-up examinations. There were no medical interventions reported. Through follow-up, the surgeon clarified there were lathe lines in the ar40 lenses. The surgeon noticed these over the past two months. One of the products was an ar40 28. 0 diopter, and he had noticed the lathe lines in other patients. The surgeon had sent pictures of the lens that he pushed through the injector quasi in vitro and then photographed it. The surgeon reported using methocel along with the standard injector to inject the lenses. The lenses remain implanted in the patients operative eyes. There are no visual acuity issues. There are no medical or surgical intervention planned and the patients have no restrictions. Through further follow-up, it was learned that the customer uses the emeraldc cartridge. The surgeon reported the issue has occurred for all ar40 lenses that they have installed in the last two months. The surgeon reported the patients tend not to notice the issue, as they just tolerate the lens pits and multifocal lenses. The surgeries were standard. The expected outcome is not perfectly clear lenses. The surgeon has alleged that the cartridges could have contributed to the scratches. The photos provided were evaluated by a subject matter expert and it was determined the images were consistent with scratches on the lens possibly caused by the cartridges. No further information was available. This report is for #2 of the 2 reported events (with ar40 28. 0 diopter). A separate report is being submitted for the cartridge with unknown number of patients.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

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 Key13516476
MDR Text Key292063434
Report Number3012236936-2022-00343
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,Followup
Report Date 06/27/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/11/2022
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 Received06/07/2022
Was Device Evaluated by Manufacturer? Yes
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: 02/11/2022 Patient Sequence Number: 1
Treatment
AR40E00280 LENS, SN UNKNOWN
-
-