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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: AMO PUERTO RICO MFG. INC. UNFOLDER PLATINUM 1 SERIES LENS, GUIDE, INTRAOCULAR

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AMO PUERTO RICO MFG. INC. UNFOLDER PLATINUM 1 SERIES LENS, GUIDE, INTRAOCULAR Back to Search Results
Model Number 1MTEC30
Device Problem Contamination (1120)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 03/01/2022
Event Type  malfunction  
Event Description
It was reported that the surgeon noticed a piece of plastic post insertion with an 1mtec30 cartridge. The piece of plastic was safely removed with no issue and was discarded. There was no patient impact. The patient status was reported as unknown. No further information was available.
 
Manufacturer Narrative
Telephone number: (b)(6). The device was not returned for analysis, 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.
 
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Brand NameUNFOLDER PLATINUM 1 SERIES
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 Key13904369
MDR Text Key289679199
Report Number3012236936-2022-00761
Device Sequence Number1
Product Code KYB
Combination Product (y/n)N
Reporter Country CodeCA
PMA/PMN Number
K081545
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 07/01/2022
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received03/25/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number1MTEC30
Device Catalogue Number1MTEC30
Device Lot NumberCJ27007
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 Received06/30/2022
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured08/04/2021
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

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