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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: AMO PUERTO RICO MFG. INC. SENSAR IOL; INTRAOCULAR LENS

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AMO PUERTO RICO MFG. INC. SENSAR IOL; INTRAOCULAR LENS Back to Search Results
Model Number AR40E
Device Problem Contamination (1120)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 10/13/2022
Event Type  malfunction  
Event Description
It was reported there was contamination of the intraocular lens (iol) when it was implanted into the patient's operative eye.The lens was replaced.There was no delay in treatment or other interventions provided.
 
Manufacturer Narrative
Implant date/explant date: lens was removed/replaced in the initial surgery.Initial reporter 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.
 
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Brand Name
SENSAR 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 Key16029230
MDR Text Key306103171
Report Number3012236936-2022-03160
Device Sequence Number1
Product Code HQL
Combination Product (y/n)N
Reporter Country CodeCH
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 Non-Healthcare Professional
Type of Report Initial
Report Date 12/21/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model NumberAR40E
Device Catalogue NumberAR40E00190
Was Device Available for Evaluation? No
Was the Report Sent to FDA? No
Initial Date Manufacturer Received 11/29/2022
Initial Date FDA Received12/21/2022
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured03/17/2022
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 Age79 YR
Patient SexMale
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