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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 03/09/2022
Event Type  malfunction  
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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 Key13904468
Report Number3012236936-2022-00757
Device Sequence Number1
Product Code KYB
Combination Product (y/n)N
Reporter Country CodeUK
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
Report Date 03/25/2022
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 Number1MTEC30S
Device Lot NumberUNKNOWN
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Date Manufacturer Received03/09/2022
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
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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