• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

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

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

AMO PUERTO RICO MFG. INC. TECNIS IOL LENS, INTRAOCULAR, TORIC OPTICS Back to Search Results
Model Number DIU300
Device Problems Crack (1135); Mechanical Jam (2983); Material Split, Cut or Torn (4008)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 03/31/2022
Event Type  malfunction  
Manufacturer Narrative
Age, weight and ethnicity: information unknown/ not provided. Per regulation eu (b)(4)(general data protection regulation), patient identifiers were not collected or recorded and therefore are not available. Implant date: not applicable, as the lens was not implanted. Explant date: not applicable, as the lens was not implanted; therefore, it was not explanted. Initial reporter - telephone number: (b)(6). Initial reporter - first/given name: unknown/not provided. The intraocular lens (iol) has 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. Attempts have been made to obtain missing information; however, no definitive response has been received. All pertinent information available to johnson & johnson surgical vision, inc. Has been submitted.
 
Event Description
It was reported that there was an intraocular lens (iol) defect and that the cartridge tip had burst. Through follow up, it was learned that on (b)(6) 2022, the surgeon went to implant the intraocular lens into the patient's operative eye, used balanced saline solution and the lens got stuck. The surgeon looked down and the cartridge tip had burst. The cartridge tip made contact with the patient's eye, but not the lens. When the surgeon later looked at the optic, he also saw that it was torn. However, the doctor stressed that this lens did not make contact with the patient, as the lens was still stuck in the cartridge. The patient was given a new lens of the same model and diopter and everything went well. Both patient and surgeon are satisfied. The surgeon is unsure if material is still available, but says he will get in touch with the quality team if it is. No other information was provided.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

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
1700 e st andrew place
santa ana, CA 92705
7142478552
MDR Report Key14190297
MDR Text Key290561381
Report Number3012236936-2022-01090
Device Sequence Number1
Product Code MJP
UDI-Device Identifier05050474727601
UDI-Public(01)05050474727601(17)241220
Combination Product (y/n)N
Reporter Country CodeGM
PMA/PMN Number
P980040
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Health Professional,User Facility,Company Representative
Reporter Occupation
Type of Report Initial
Report Date 04/22/2022
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received04/22/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberDIU300
Device Catalogue NumberDIU300I200
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Date Manufacturer Received03/31/2022
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured12/20/2021
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

-
-