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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 DIU150
Device Problems Delivered as Unsterile Product (1421); Manufacturing, Packaging or Shipping Problem (2975)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 04/27/2022
Event Type  malfunction  
Event Description
It was reported that the seal was broken when it arrived. The customer did not trust the sterility since the inner wrap is a single wrap. There was no reported patient contact. No additional information was provided.
 
Manufacturer Narrative
Patient information not applicable, as there was no patient involvement. If implanted, give date: not applicable, as there was no patient involvement. If explanted, give date: not applicable, as there was no patient involvement. The device was 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 and johnson surgical vision, inc. Has been submitted.
 
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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 Key14491779
MDR Text Key292604739
Report Number3012236936-2022-01244
Device Sequence Number1
Product Code MJP
UDI-Device Identifier05050474746534
UDI-Public(01)05050474746534(17)240824
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 05/24/2022
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received05/24/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberDIU150
Device Catalogue NumberDIU150U195
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Date Manufacturer Received04/27/2022
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured08/24/2021
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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