Recall Z-2407-2023

Alcon Research, LTD. · initiated June 28, 2023

Class II Open, Classified

Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature

Product

Centurion FMS Pak

Codes / lots: Catalog No. 8065000133, 8065000134, 8065000138, 8065000139, 8065752192, 8065752193, 8065752200, 8065752201, 8065752202, 8065752203, 8065752216, 8065752217, 8065752245, 8065752917, 8065752918, 8065753134, 8065753135, 8065753136, 8065753159; Product Code 100241014, 100241015, 100241019, 100241020, 100055107, 100055110, 100009955, 100009963, 100009964, 100009965, 100009960, 100009961, 100010766, 100056645, 100055945, 100207171, 100207170, 100208838, 100208338; UDI-DI: 380650001337, 380650001344, 380650001382, 380650001399, 380657521920, 380657521937, 380657522002, 380657522019, 380657522026, 380657522033, 380657522163, 380657522170, 380657522453, 380657529179, 380657529186, 380657531349, 380657531356, 380657531363, 380657531592; Lots 14WW1F, 14WW1H, 14WW1J, 14X6CN, 14X6CP, 14X6CR, 14X6CT, 14X6CU, 14X6CV, 14XPE9, 14XPEA, 14XPEC, 14XPED, 14XPEE, 14XPEF, 14XPEH, 14Y8C2, 14Y8C3, 14Y8C4, 14Y8C5, 14Y8C6, 14Y8C7, 14YLMF, 14YLMH, 14YLMJ, 14YLMK, 14YLML, 14YLMM, 14YLMN, 14YLMP, 14YXHY, 14YXJ0, 14YXJ1, 14YXJ3, 14YXJ4, 14YXJ5, 14YXJ6, 14YXJ7, 150HDA, 150HDC, 150HDD, 150HDE, 150HDF, 150HDH, 150HDJ, 150HDK, 150HDL, 150HDM, 150HDN, 150HDP, 150HDR, 151V90, 151V91, 151V92, 151V93, 151V94, 151V95…

Reason for recall

Reports of patient injury during use in procedures due to potential for plastic debris from over-tightening with included plastic wrench.

FDA-determined cause: Process control

Action taken

Customers were sent a Voluntary Medical Device Correction Notification by mail and dated 06/29/2023. Customers are asked to follow the risk mitigation precautions detailed in the notice to avoid the instance of overtightening the Phaco Tip and generating plastic particles. Additionally, customers are asked to forward the recall notification to all departments or organizations that use recalled devices. Customers are asked to complete and return the provided Response Form by fax at 817-302-4337 or email at Market.Actions@alcon.com. Customers who have experienced any adverse events or quality related issues are to contact alcon via email at msus.safety@alcon.com or by phone at 1-800-757-9780, Option 5.

Details

Recall number
Z-2407-2023
Initiated
June 28, 2023
Posted by FDA
August 16, 2023
Product code
HQC – Unit, Phacofragmentation
Quantity
87,839 units
Distribution
Worldwide distribution - US Nationwide and the countries of Aland Islands, Albania, Algeria, Andorran, Argentina, Armenia, Aruba, Australia, Austria, Azerbaijan, Bahamas, Bahrain, Bangladesh, Barbados, Belarus, Belgium, Bermuda, Botswana, Brazil, Brunei Daruss., Bulgaria, Burma, Cambodia, Canada, Cayman Islands, Chile, China, Colombia, Costa Rica, Croatia, Cura¿ao, Cyprus, Czech Republic…
Recalling firm
Alcon Research, LTD., Sinking Spring, PA

Official FDA recall record

Other products in the same recall event

RecallProductInitiated
Z-2406-2023 Class IIConstellation Procedure PakReports of patient injury during use in procedures due to potential for plastic debris from over-tightening… 06/28/2023Open, Classified
Z-2408-2023 Class IIInfinity FMS PakReports of patient injury during use in procedures due to potential for plastic debris from over-tightening… 06/28/2023Open, Classified
Z-2409-2023 Class IILegion FMS PakReports of patient injury during use in procedures due to potential for plastic debris from over-tightening… 06/28/2023Open, Classified
Z-2410-2023 Class IIPhaco Standalone TipsReports of patient injury during use in procedures due to potential for plastic debris from over-tightening… 06/28/2023Open, Classified
Z-2411-2023 Class IIAlcon Custom PakReports of patient injury during use in procedures due to potential for plastic debris from over-tightening… 06/28/2023Open, Classified