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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 04/22/2022
Event Type  malfunction  
Manufacturer Narrative
Age or dob, weight, ethnicity: not applicable, as there was no patient contact with the product. Implant date: if implanted, give date: not applicable, no patient contact with the product. Explant date: if explanted, give date: not applicable, no patient contact with the product. Initla reporter name and address: telephone number: (b)(6). 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 & johnson surgical vision, inc. Has been submitted.
 
Event Description
It was reported that the preloaded device popped out when the package was opened and dropped to the floor. Account indicated that the packaging was not sealed properly and effectively enough that it opened far too easily, causing the injector to pop too quickly. As the seal was not strong enough to hold the package together, there was a concern with the sterility of the device. No further information was provided.
 
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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 Key14438630
MDR Text Key292184577
Report Number3012236936-2022-01306
Device Sequence Number1
Product Code MJP
UDI-Device Identifier05050474726420
UDI-Public(01)05050474726420(17)240912
Combination Product (y/n)N
Reporter Country CodeCA
PMA/PMN Number
P980040
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Health Professional,User Facility
Reporter Occupation
Type of Report Initial,Followup
Report Date 08/17/2022
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received05/19/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberDIU150
Device Catalogue NumberDIU150I200
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 Received07/26/2022
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured09/12/2021
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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