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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 Problems Operating System Becomes Nonfunctional (2996); Material Split, Cut or Torn (4008)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 12/09/2021
Event Type  malfunction  
Manufacturer Narrative
Patient age and date of birth, patient weight, and ethnicity and race: unknown as information was asked but not provided. Date explanted: not applicable as the iol remains implanted. It was indicated that the iol is not being returned for evaluation as it remains implanted. Therefore, a visual analysis of the complaint device cannot be completed. A review of the device/lot history record and historical data analysis for this device will be performed. Upon completion of the review, if there is any further relevant information a supplemental medwatch report will be filed. Attempts were made to obtain further information; however, no response has been received. All pertinent information available to johnson & johnson surgical vision, inc. Has been submitted.
 
Event Description
It was reported that, after implantation into the patient's operative eye, the pre-loaded intraocular lens (iol) had a cut in the optic; account indicated that the cut is not all the way through the lens. Upon consulting with the account, the sales representative believes that the plunger is cutting the lens. No surgical intervention is scheduled at this time. The patient is being monitored. The iol is not being returned as it remains implanted. No further information 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 Key13172854
MDR Text Key286643762
Report Number3012236936-2022-00035
Device Sequence Number1
Product Code MJP
UDI-Device Identifier05050474747005
UDI-Public(01)05050474747005(17)241009
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,Company Representative
Reporter Occupation
Type of Report Initial
Report Date 01/05/2022
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received01/05/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberDIU225
Device Catalogue NumberDIU225U135
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Date Manufacturer Received12/09/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured10/09/2021
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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