• 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; INTRAOCULAR LENS

  • 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; INTRAOCULAR LENS Back to Search Results
Model Number ZA9003
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Blurred Vision (2137); Visual Disturbances (2140); Eye Pain (4467); Unspecified Eye / Vision Problem (4471)
Event Type  Injury  
Manufacturer Narrative
Section b3: date of event: unknown, not provided.The best estimate date is on or after mar 5, 2024.Section d6b: if explanted, give date: not applicable as the device remains implanted.Section h3-other (81): the device was not returned for evaluation as the lens remains implanted; 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 were made to obtain missing information; however, no definitive response was received.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.
 
Event Description
A patient initially reported that his left eye vision looks cracked.His doctor told him to use eye drops for five (5) days.The patient has pain in his eye, cannot sleep, does not see clear and still sees blurry.In follow ups with the patient, he indicated he sees a white light on the side of the eye, his vision is bad, that he has pain in his eyeball with watery eye.The patient last saw his doctor two weeks ago, but no explanation was provided to the patient by his doctor.The patient has been given a pill and 10-12 eye drops which he is still using them (the name of medications was not provided as the patient did not have that information).It was confirmed that no laser procedure or other surgical interventions have been performed on the patient¿s eye.The patient indicated he is not able to perform his daily activities as he used to before the surgery, that he cannot drive.The patient has asked the doctor to explant and replace the lens.No other information was provided.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
TECNIS IOL
Type of Device
INTRAOCULAR LENS
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 Key19131457
MDR Text Key340448970
Report Number3012236936-2024-01142
Device Sequence Number1
Product Code HQL
UDI-Device Identifier05050474529038
UDI-Public(01)05050474529038(17)271023
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
P990080
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Consumer
Reporter Occupation Non-Healthcare Professional
Type of Report Initial
Report Date 04/17/2024
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Device Model NumberZA9003
Device Catalogue NumberZA90030210
Was Device Available for Evaluation? No
Was the Report Sent to FDA? No
Initial Date Manufacturer Received 03/22/2024
Initial Date FDA Received04/18/2024
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured10/23/2022
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
Patient Age73 YR
Patient SexMale
Patient Weight64 KG
Patient EthnicityNon Hispanic
Patient RaceAsian
-
-