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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 ZCT300
Device Problem Manufacturing, Packaging or Shipping Problem (2975)
Patient Problems Eye Injury (1845); Inflammation (1932); Visual Impairment (2138)
Event Date 11/02/2021
Event Type  Injury  
Manufacturer Narrative
If implanted, give date: unknown/not provided. (b)(6). The intraocular lens (iol) 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 two (2) intraocular lenses (iols) were glued in the same package, and realized later that the 2 lenses were implanted. Physician separated the lenses and proceeded to explant one of the two lenses, leaving a single lens in the conjunctival sac. Through follow-up, they proceeded to evaluate the patient, finding the cornea very inflamed. Referring to visual acuity, they point out that it is at +25, however, because the eye is so inflamed, they must wait until the next visit to know the visual acuity. The patient will be left with the remaining iol in order to be able to corroborate that the lens was indeed the correct one. 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 Key12928861
MDR Text Key285714625
Report Number3012236936-2021-00168
Device Sequence Number1
Product Code MJP
UDI-Device Identifier05050474539129
UDI-Public(01)05050474539129(17)250612
Combination Product (y/n)N
Reporter Country CodeCI
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,Followup
Report Date 06/09/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/03/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberZCT300
Device Catalogue NumberZCT3000090
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Date Manufacturer Received05/11/2022
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured06/12/2021
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 12/03/2021 Patient Sequence Number: 1
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