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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ALCON MICROSURGICAL INSTRUMENTS, CANNULA OPHTHALMIC; CANNULA, OPHTHALMIC
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ALCON MICROSURGICAL INSTRUMENTS, CANNULA OPHTHALMIC; CANNULA, OPHTHALMIC Back to Search Results
Catalog Number 8065149525
Medical Device Problem Code Fitting Problem (2183)
Health Effect - Clinical Code No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event Malfunction
Additional Manufacturer Narrative
Investigation including root cause analysis is in progress.A supplemental mdr will be filed as necessary in accordance with 21 cfr 803.56 when additional reportable information becomes available.The manufacturer internal reference number is: (b)(4).
 
Event or Problem Description
A nurse reported that during cataract surgery the soft tip extrusion cannulas were stuck in mid shaft of the trocars and they seems to be rough in that section of the cannula or not quite straight.The procedure was completed by using other cannula.The patient harm was not provided.Additional information has been requested.
 
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Brand Name
ALCON MICROSURGICAL INSTRUMENTS, CANNULA OPHTHALMIC
Common Device Name
CANNULA, OPHTHALMIC
MDR Report Key12342318
Report Number2523835-2021-00306
Device Sequence Number14554625
Product Code HMX
UDI-Device Identifier00380651495258
UDI-Public00380651495258
Combination Product (Y/N)N
Initial Reporter CountryCA
PMA/510(K) Number
EXEMPT
Number of Events Summarized1
Summary Report (Y/N)N
Reporter Type Manufacturer
Report Source company representative,foreig
Initial Reporter Occupation Nurse
Type of Report Initial
Report Date (Section B) 08/19/2021
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
Operator of Device Health Professional
Device Catalogue Number8065149525
Device Lot NumberASKU
Was Device Available for Evaluation? No
Type of Report(Section G)Initial
Initial Date Received by Manufacturer 07/23/2021
Initial Report FDA Received Date08/19/2021
Was Device Evaluated by Manufacturer? (Y/N) Device Not Returned to Manufacturer
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Usage of Device Initial
Patient Sequence Number1
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