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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: AMO PUERTO RICO MFG. INC. TECNIS IOL LENS, INTRAOCULAR, TORIC OPTICS

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AMO PUERTO RICO MFG. INC. TECNIS IOL LENS, INTRAOCULAR, TORIC OPTICS Back to Search Results
Model Number DIU225
Device Problem Material Split, Cut or Torn (4008)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 07/13/2022
Event Type  malfunction  
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Brand NameTECNIS IOL
Type of DeviceLENS, INTRAOCULAR, TORIC OPTICS
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 Key15214974
Report Number3012236936-2022-02070
Device Sequence Number1
Product Code MJP
UDI-Device Identifier05050474747135
UDI-Public(01)05050474747135(17)240122
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
P980040
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Health Professional,User Facility
Reporter Occupation
Type of Report Initial
Report Date 08/11/2022
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received08/11/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberDIU225
Device Catalogue NumberDIU225U200
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Date Manufacturer Received07/18/2022
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured01/22/2021
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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