|
Class 2 Device Recall Alcon Custom Pak |
|
Date Initiated by Firm |
March 15, 2024 |
Date Posted |
April 22, 2024 |
Recall Status1 |
Open3, Classified |
Recall Number |
Z-1606-2024 |
Recall Event ID |
94253 |
510(K)Number |
K880961
|
Product Classification |
General surgery tray - Product Code LRO
|
Product |
Various Alcon Custom Paks Surgical Procedure Pack containing Oasis 27Ga Chang Hydrodissection Cannulas. These Custom Paks are surgical procedure packs used by ophthalmic surgeons in a variety of ophthalmic surgeries. The Custom Pak is a collection of various ophthalmic surgical instruments and necessary materials. Below are the various Alcon Customer Paks and Pak REF Numbers:
0515-66 ELMENDORF AFB CATARACT 3RD MED CTR
0752-74 CATARACT V A MED CTR
1119-82 DR DAVID B LEACH PALOUSE SURGERY CENTER
11401-13 CATARACT SUTTER SOLANO MED CTR
11910-32 DAVISON-SAGGAU CATARACT WOLFE EYE SURGER
11912-26 30 DEG CATARACT BASE PACK WOLFE EYE SUR
11913-23 JOHNSON CATARACT WOLFE EYE SURGERY CENTE
12185-14 CATARACT LASERVUE EYE CENTER
12213-12 CATARACT TULSA SPINE AND SPECIALTY
12213-13 CATARACT TULSA SPINE AND SPECIALTY
12213-15 CATARACT TULSA SPINE AND SPECIALTY
12213-16 CATARACT TULSA SPINE AND SPECIALTY
12643-06 CATARACT PACK OCHSNER BAPTIST MED CTR
12931-17 JOHNSON CATARACT GREATER COMMUNITY HOSP
12942-18 CONRAD PHYSICIANS MEDICAL CENTER
12942-19 CONRAD PHYSICIANS MEDICAL CENTER
13567-10 OPHTHALMIC PHYSICIANS SURG CTR
13948-15 DR RHEE PACK MARSHALLTOWN MED/SURG CNT
13970-11 CATARACT GWINNETT CTR OUTPT SURG
13970-12 CATARACT GWINNETT CTR OUTPT SURG
14389-08 INFINITI STAMFORD SURGICAL CENTER
14408-12 E-Z PACK QUEEN OF THE VALLEY
14408-13 E-Z PACK QUEEN OF THE VALLEY
14533-18 OPHTHALMIC UOFL HOSPITAL
15209-05 CATARACT NORTH ATLANTA EYE SURGERY CTR
15354-16 DR RAUEN WOLFE EYE SURGERY CENTER LLC
15435-13 EPS 2.2 PACK IOWA CITY AMBULATORY SURGER
15502-10 DR NEWCOMB LEXINGTON CLINIC
15639-12 DR RAUEN LUCAS COUNTY HEALTH CTR
15678-13 DR RAUEN CLARKE COUNTY HOSPITAL
15965-12 DR LEVAR CHRISTUS SANTA ROSA ASC
16001-12 DR YONKER/BESCAK CESC
16001-13 DR YONKER/BESCAK CESC
16013-12 DR MCDONALD NORTH FL SURG PAVILION
16086-07 DR DAVID B LEACH PULLMAN MEMORIAL HOSPIT
16177-08 OPHTHALMIC DENVER EYE SURG CTR
16204-13 CATARACT V A HOSPITAL
16450-10 DR GROSS/GUSSLER KINGS DAUGHTERS HOSPITA
16452-06 RAECKER PACK GREATER COMMUNITY HOSP
16633-08 CATARACT DUOVISC RETINA SPECIALISTS NJ
16644-08 DR BALES HOSPITAL PACK NATIVE INVESTMENT
16644-09 DR BALES HOSPITAL PACK NATIVE INVESTMENT
16798-08 CATARACT HAUSER ROSS EYE INSTITUTE
16820-06 PHACO LONE PEAK SURGERY CENTER
17029-09 DR ICON CATARACT DAY SURGERY OF GRAND JU
17201-18 SILVERA VALLEY SURGERY CENTER
17340-08 EPS 2.2 PACK WASHINGTON COUNTY HOSP
17354-07 EPS 2.2 PACK HENRY COUNTY HEALTH CTR
17361-08 MICRO PAK CARLE FOUNDATION HOSP
17382-05 CATARACT BILLINGS VA MEDICAL CENTE
17382-07 CATARACT BILLINGS VA MEDICAL CENTE
17507-02 DR CAMPAGNA NORTH CENTRAL METH ASC
17520-05 DR GROSS CHARLESTON SURGERY CTR
17526-09 CPK0926-CROSBY-DONG-GADLIN-JAC VANTAGE O
17529-09 CPK0927 AESC VANTAGE OUTSOURCING
17541-07 HAIDER DUPONT SURG CTR
17541-08 HAIDER DUPONT SURG CTR
17617-05 DR CHUNG CATARACT PACK ST HELENA HOSPITA
17651-06 DMEK-DSEK-CAT CENTER FOR ADVANCED SURGER
17653-06 DR HUNT CHARLESTON AREA MED CTR
17671-06 CATARACT EDMONDS CENTER FOR OUTPAT
17671-07 CATARACT EDMONDS CENTER FOR OUTPAT
17740-06 DR ESPANDAR ARMSTRONG CO MEM HOSP
17740-07 DR ESPANDAR ARMSTRONG CO MEM HOSP
17740-08 DR ESPANDAR ARMSTRONG CO MEM HOSP
17773-09 DR ESPANDAR JAMESON MEMORIAL HOSPITAL
17930-08 CATARACT PACK NORTHERN PLAINS SURG CTR
17966-06 TURNER CATARACT WOLFE EYE SURGERY CENTER
17987-05 OPHTHALMIC SEATTLE SURGERY CENTER
18069-04 DR WENTWORTH CATARACT GREENVIEW SURGERY
18123-05 CATARACT BOWERS INNOVATIVE EYE SURGERY C
18208-09 CATARACT SUTTER FAIRFIELD SURG CTR
18382-04 DR GEORGE ZAMBELLI BEAVER VALLEY ASC
18382-06 DR GEORGE ZAMBELLI BEAVER VALLEY ASC
18384-04 DR BURKS SPRINGHILL SURGERY CENTER
18401-04 MCGRAW SIGHTPATH MEDICAL
18406-03 DR KUCHINKA HAYWARD AREA HOSP
18427-07 CATARACT V A HOSPITAL
18427-08 CATARACT V A HOSPITAL
18431-06 VISION EYE SC VISION EYE SURGERY CENTER
18445-03 K LEE/LIN CALIFORNIA PACIFIC MED CT
18550-04 DR HU TORRES CAT & LSR CNTRL
18555-04 DR WU - CENTURION CAT & LSR CNTRL
18636-10 CATARACT BONNER GENERAL HOSPITAL |
Code Information |
Pak Number/Product Desp/GTIN/UDI:
0515-66 ELMENDORF AFB CATARACT 3RD MED CTR
380655168448 H5301ALCON1CPAK10
Lot Numbers:
JZ5201911
JZ5202956
0752-74 CATARACT V A MED CTR
380653425277 H5301ALCON1CPAK10
Lot Numbers:
JZ5180248
JZ5181442
JZ5193970
JZ5199465
JZ5200775
16JYUR
1119-82 DR DAVID B LEACH PALOUSE SURGERY CENTER
380651661752 H5301ALCON1CPAK10
Lot Numbers:
JZ5180968
15XVDX
JZ5185253
JZ5186896
JZ5189654
JZ5194999
JZ5195815
JZ5200769
JZ5201588
11401-13 CATARACT SUTTER SOLANO MED CTR
380651681347 H5301ALCON1CPAK10
Lot Numbers:
160RRK
163XWD
165YVA
1681H3
169RYX
16A4UF
16KACN
11910-32 DAVISON-SAGGAU CATARACT WOLFE EYE SURGER
380655151587 H5301ALCON1CPAK10
Lot Numbers:
15UXH3
15W9DE
15XE9V
15YE10
1628K4
1646KW
1657E6
1687N8
169J7K
16AHR0
16D2VP
11912-26 30 DEG CATARACT BASE PACK WOLFE EYE SUR
380655158135 H5301ALCON1CPAK10
Lot Numbers:
15UWHC
15VAEH
15VWP3
15WC2N
15YJRJ
15YJT2
15YJTA
15YJTD
15YLT6
15YLT7
15YLV0
15YLWE
164R3F
1681HR
1683U4
1689KU
1689LH
169T02
16AUVP
16C497
16EE2D
16EE31
16EHCT
16JWXT
16KKDF
16KR3J
11913-23 JOHNSON CATARACT WOLFE EYE SURGERY CENTE
380655156513 H5301ALCON1CPAK10
Lot Numbers:
161CX3
164057
12185-14 CATARACT LASERVUE EYE CENTER
380651662698 H5301ALCON1CPAK10
Lot Numbers:
161HT2
166DNN
166DPV
167XAY
168J0C
16D31W
16FVYU
16JLLM
12213-12 CATARACT TULSA SPINE AND SPECIALTY
380655142332 H5301ALCON1CPAK10
Lot Numbers:
JZ5180099
JZ5180703
JZ5182416
12213-13 CATARACT TULSA SPINE AND SPECIALTY
380655159736 H5301ALCON1CPAK10
Lot Numbers:
JZ5194624
JZ5186533
JZ5190784
JZ5195054
12213-15 CATARACT TULSA SPINE AND SPECIALTY
380655167045 H5301ALCON1CPAK10
Lot Number:
16DY06
12213-16 CATARACT TULSA SPINE AND SPECIALTY
380655168899 H5301ALCON1CPAK10
Lot Numbers:
16JCD3
JZ5205295
16JYW4
12643-06 CATARACT PACK OCHSNER BAPTIST MED CTR
380655142530 H5301ALCON1CPAK10
Lot Numbers:
JZ5179405
JZ5179791
JZ5179793
15UMDX
JZ5183399
JZ5185544
161WC3
JZ5185546
164NV6
166CF1
166CF6
169K47
169VJC
16AYM1
16EP3E
16ERDY
16H78W
16H7A0
16JJ75
12931-17 JOHNSON CATARACT GREATER COMMUNITY HOSP
380655151082 H5301ALCON1CPAK10
Lot Numbers:
15VJUE
161A9X
12942-18 CONRAD PHYSICIANS MEDICAL CENTER
380655136058 H5301ALCON1CPAK10
Lot Number:
168F5E
12942-19 CONRAD PHYSICIANS MEDICAL CENTER
380655169681 H5301ALCON1CPAK10
Lot Number:
16F8PN
13567-10 OPHTHALMIC PHYSICIANS SURG CTR
380655148365 H5301ALCON1CPAK10
Lot Numbers:
JZ5180061
15UTNR
15VP7K
JZ5182727
JZ5183496
1641VT
164PYY
1664DR
166KMA
167VJ2
168PW9
169NKL
169NKN
16AUX1
16D31C
16D3EU
16ENFD
JZ5200243
JZ5200239
JZ5201252
16FC7K
16FD6A
13948-15 DR RHEE PACK MARSHALLTOWN MED/SURG CNT
380651661653 H5301ALCON1CPAK10
Lot Numbers:
15V7VC
15YTL0
16EK48
16HV9P
16KTDN
16KV3J
13970-11 CATARACT GWINNETT CTR OUTPT SURG
380655153581 H5301ALCON1CPAK10
Lot Numbers:
JZ5180411
JZ5180409
13970-12 CATARACT GWINNETT CTR OUTPT SURG
380655163511 H5301ALCON1CPAK10
Lot Numbers:
JZ5195307
JZ5195305
16ACFA
16CW8X
16E005
16F3H9
JZ5201679
JZ5201681
JZ5202345
JZ5202347
16H4C7
16HCD2
14389-08 INFINITI STAMFORD SURGICAL CENTER
380653418811 H5301ALCON1CPAK10
Lot Numbers:
16ANV6
16EE39
14408-12 E-Z PACK QUEEN OF THE VALLEY
380651699090 H5301ALCON1CPAK10
Lot Numbers:
1637KP
163A2K
163A2L
1654AX
1694P1
16AAKP
14408-13 E-Z PACK QUEEN OF THE VALLEY
380655169865 H5301ALCON1CPAK10
Lot Number:
16J3V0
14533-18 OPHTHALMIC UOFL HOSPITAL
380655128893 H5301ALCON1CPAK10
Lot Numbers:
15TDRD
JZ5187567
162V0V
JZ5188305
1646L8
166KRH
167F66
1689PX
JZ5196723
169Y7X
JZ5196725
15209-05 CATARACT NORTH ATLANTA EYE SURGERY CTR
380655119266 H5301ALCON1CPAK10
Lot Numbers:
JZ5182015
JZ5179828
JZ5182017
JZ5182019
JZ5182021
JZ5182023
JZ5182025
JZ5189545
JZ5189547
1683UH
JZ5193687
JZ5193689
JZ5193693
JZ5193691
JZ5193695
JZ5194353
JZ5194347
JZ5194349
169624
169J38
16EJNU
16EK31
16EK3F
16ERDT
16F1Y8
16F5KY
16F5L7
16FU6F
16H79A
16HE8M
16HHPC
16HLN4
16KNX3
15354-16 DR RAUEN WOLFE EYE SURGERY CENTER LLC
380651669154 H5301ALCON1CPAK10
Lot Numbers:
15URRF
15VH42
15X4TK
163KMN
15435-13 EPS 2.2 PACK IOWA CITY AMBULATORY SURGER
380651696761 H5301ALCON1CPAK10
Lot Numbers:
JZ5181119
JZ5181117
JZ5196980
16CTW0
JZ5198018
JZ5202443
16J9TD
16KP1U
15502-10 DR NEWCOMB LEXINGTON CLINIC
380651659216 H5301ALCON1CPAK10
Lot Numbers:
15VWRR
15YTL6
16354H
164NVE
168F5L
169J44
16AKCV
16CWXJ
16DJ2K
16H03D
16JEP1
16KFCX
15639-12 DR RAUEN LUCAS COUNTY HEALTH CTR
380651662247 H5301ALCON1CPAK10
Lot Numbers:
166XP7
16C3UV
16DJ3V
16KWHA
15678-13 DR RAUEN CLARKE COUNTY HOSPITAL
380651661172 H5301ALCON1CPAK10
Lot Numbers:
160H15
16KWHD
15965-12 DR LEVAR CHRISTUS SANTA ROSA ASC
380655147849 H5302ALCON2CPAK20
Lot Numbers:
15Y1VM
161CWF
1644WE
1673RU
1689LK
16A4WT
16C9X6
16J2F2
16001-12 DR YONKER/BESCAK CESC
380655139660 H5301ALCON1CPAK10
Lot Numbers:
JZ5180191
JZ5181344
15VAHL
16096T
16273U
164VL5
16734V
167W3J
169A11
16EE2H
16001-13 DR YONKER/BESCAK CESC
380655171158 H5302ALCON2CPAK20
Lot Numbers:
16J2HU
16KA4P
16013-12 DR MCDONALD NORTH FL SURG PAVILION
380651674004 H5301ALCON1CPAK10
Lot Numbers:
161MY7
162223
JZ5187506
1689M3
169AEM
16AKEA
JZ5196677
JZ5197622
JZ5200898
16FC7P
JZ5202375
JZ5203185
16086-07 DR DAVID B LEACH PULLMAN MEMORIAL HOSPIT
380651661769 H5301ALCON1CPAK10
Lot Numbers:
15V1HL
166DNC
169159
16177-08 OPHTHALMIC DENVER EYE SURG CTR
380655157817 H5301ALCON1CPAK10
Lot Numbers:
15UW01
15V1CJ
1612U0
161TEL
162WJC
163538
163RCP
16511H
1655CY
1655E2
167ATY
1688PU
JZ5193937
JZ5193933
JZ5193931
JZ5193935
JZ5201037
JZ5198450
JZ5201039
16F3D5
JZ5204193
JZ5204191
16J854
16JKM5
16JLM8
JZ5203397
JZ5203395
JZ5203399
JZ5205000
16K87P
16204-13 CATARACT V A HOSPITAL
380651672123 H5301ALCON1CPAK10
Lot Numbers:
15UTMT
15XHV5
160KD6
161PLJ
164EDC
167VJE
1699HP
169UNA
16AYJ6
16E0H7
16F5LV
16KTC2
16450-10 DR GROSS/GUSSLER KINGS DAUGHTERS HOSPITA
380651700826 H5301ALCON1CPAK10
Lot Numbers:
15V674
160WNH
16AUW2
16452-06 RAECKER PACK GREATER COMMUNITY HOSP
380655147382 H5301ALCON1CPAK10
Lot Numbers:
15VEPP
168LC6
168LCX
16E2RV
16J2FC
16633-08 CATARACT DUOVISC RETINA SPECIALISTS NJ
380655126097 H5301ALCON1CPAK10
Lot Numbers:
JZ5183821
JZ5187052
JZ5199244
16EV7V
16J889
JZ5204459
JZ5204684
JZ5204457
JZ5205136
16644-08 DR BALES HOSPITAL PACK NATIVE INVESTMENT
380651659971 H5301ALCON1CPAK10
Lot Numbers:
JZ5180177
JZ5182256
164CKH
166MYH
16644-09 DR BALES HOSPITAL PACK NATIVE INVESTMENT
380655164778 H5301ALCON1CPAK10
Lot Numbers:
JZ5194680
16ARFT
JZ5196164
16DTA1
JZ5203259
16HCE3
16798-08 CATARACT HAUSER ROSS EYE INSTITUTE
380655119747 H5301ALCON1CPAK10
Lot Numbers:
JZ5181173
JZ5181175
JZ5181171
JZ5188259
JZ5188257
JZ5190516
JZ5190514
JZ5198210
JZ5200926
JZ5200924
16KA5L
16KEKE
16820-06 PHACO LONE PEAK SURGERY CENTER
380651666511 H5301ALCON1CPAK10
Lot Numbers:
15W2VD
1610P2
163RCL
169NKH
16A4UE
16C6UR
16HMVA
16K6LP
17029-09 DR ICON CATARACT DAY SURGERY OF GRAND JU
380651661318 H5301ALCON1CPAK10
Lot Numbers:
15UYWE
15W8DE
15YCAD
15YLVE
160NP9
162WV4
164ET1
164TX4
1681F9
168CY5
168R6V
16A6ML
16ATXM
16D7WW
16DN79
16HFM8
16K1VF
16K1VK
17201-18 SILVERA VALLEY SURGERY CENTER
380655157657 H5301ALCON1CPAK10
Lot Numbers:
15WVAA
15XD82
167MVD
167W3U
169M2C
169T25
16DVKX
16KA59
16KJMF
17340-08 EPS 2.2 PACK WASHINGTON COUNTY HOSP
380651696785 H5301ALCON1CPAK10
Lot Numbers:
15WPF0
160H1R
165YV6
1662C2
168PWA
16DTAJ
16DTC0
16EH2C
17354-07 EPS 2.2 PACK HENRY COUNTY HEALTH CTR
380655134528 H5301ALCON1CPAK10
Lot Numbers:
15UTNX
1673TC
168M3N
17361-08 MICRO PAK CARLE FOUNDATION HOSP
380651696747 H5301ALCON1CPAK10
Lot Numbers:
15VERA
15WTX3
1616K9
JZ5190118
16354N
163XWJ
163XWN
166A8C
166YH6
16852A
16852V
16855T
JZ5193699
JZ5193701
JZ5194148
JZ5194150
JZ5200707
JZ5200705
16F01E
JZ5201205
JZ5201203
16F5M6
17382-05 CATARACT BILLINGS VA MEDICAL CENTE
380655158548 H5301ALCON1CPAK10
Lot Numbers:
15VT7J
164TY3
17382-07 CATARACT BILLINGS VA MEDICAL CENTE
380655165027 H5301ALCON1CPAK10
Lot Number:
1696C9
17507-02 DR CAMPAGNA NORTH CENTRAL METH ASC
380651676138 H5302ALCON2CPAK20
Lot Numbers:
15X991
16716N
16A2HX
16DN5K
16JLLW
17520-05 DR GROSS CHARLESTON SURGERY CTR
380651663381 H5301ALCON1CPAK10
Lot Number:
JZ5187064
168CUU
17526-09 CPK0926-CROSBY-DONG-GADLIN-JAC VANTAGE O
380651678842 H5301ALCON1CPAK10
Lot Numbers:
15XLME
163KLN
163V3R
164A33
1688R1
169CK3
16D8W7
16F4MM
16HK3T
16KFDN
17529-09 CPK0927 AESC VANTAGE OUTSOURCING
380651657601 H5301ALCON1CPAK10
Lot Numbers:
15X4RH
163KKT
1646TM
165HYC
168PY0
16A24N
16D8W4
16J6EV
16K6M0
17541-07 HAIDER DUPONT SURG CTR
380655160985 H5302ALCON2CPAK20
Lot Number:
15X18M
17541-08 HAIDER DUPONT SURG CTR
380655165645 H5302ALCON2CPAK20
Lot Numbers:
168F65
16A9K9
17617-05 DR CHUNG CATARACT PACK ST HELENA HOSPITA
380655143353 H5301ALCON1CPAK10
Lot Numbers:
15W11A
160WNE
164353
1668VE
16A31E
16JNAR
17651-06 DMEK-DSEK-CAT CENTER FOR ADVANCED SURGER
380655146606 H5301ALCON1CPAK10
Lot Numbers:
JZ5180562
15WWJC
15Y1V6
16097R
1637LD
163V32
163V4A
JZ5189819
165AXT
JZ5189817
1664HV
166YHH
167J8W
167TC5
167W31
168J09
JZ5194495
JZ5193813
JZ5193811
JZ5193809
JZ5194489
JZ5193807
JZ5194491
JZ5194493
1698JY
169E7C
169F6A
JZ5195434
JZ5195428
JZ5195430
JZ5195432
JZ5201592
JZ5201590
JZ5202435
17653-06 DR HUNT CHARLESTON AREA MED CTR
380655142066 H5302ALCON2CPAK20
Lot Numbers:
15WUUN
160696
1633CH
1657EE
1690H7
16ATTW
17671-06 CATARACT EDMONDS CENTER FOR OUTPAT
380655147405 H5301ALCON1CPAK10
Lot Numbers:
15UX9J
15VH5J
17671-07 CATARACT EDMONDS CENTER FOR OUTPAT
380655161357 H5301ALCON1CPAK10
Lot Numbers:
15YTLM
164A37
1658XR
16807U
169RXX
169T05
16C3TP
16E2T4
16EU0Y
16K3LP
17740-06 DR ESPANDAR ARMSTRONG CO MEM HOSP
380655156728 H5301ALCON1CPAK10
Lot Number:
160WMV
17740-07 DR ESPANDAR ARMSTRONG CO MEM HOSP
380655163351 H5301ALCON1CPAK10
Lot Numbers:
1647N0
1682R7
168PXR
16AJ0E
17740-08 DR ESPANDAR ARMSTRONG CO MEM HOSP
380655169186 H5301ALCON1CPAK10
Lot Numbers:
16HHP3
16J85W
17773-09 DR ESPANDAR JAMESON MEMORIAL HOSPITAL
380655152034 H5301ALCON1CPAK10
Lot Numbers:
15V1CP
15XLNC
15YV2R
162LRX
164NV2
16851D
16ENDF
16K86D
16KMT4
17930-08 CATARACT PACK NORTHERN PLAINS SURG CTR
380651698741 H5301ALCON1CPAK10
Lot Numbers:
15X103
15XHRA
160RTK
166DR8
166V71
16719A
1687PL
16A80D
16DXK2
16DY09
16EW7J
16KLK3
17966-06 TURNER CATARACT WOLFE EYE SURGERY CENTER
380651669178 H5301ALCON1CPAK10
Lot Numbers:
15VH7H
15VKL4
15WWJ1
15XHD6
167LLC
17987-05 OPHTHALMIC SEATTLE SURGERY CENTER
380655147856 H5301ALCON1CPAK10
Lot Numbers:
15UNTM
15WAXK
160HMD
1646TX
164TYF
166KN1
18069-04 DR WENTWORTH CATARACT GREENVIEW SURGERY
380651673502 H5301ALCON1CPAK10
Lot Numbers:
15VWPU
15Y1W5
160YK5
161HRH
164A4P
167UFD
168M2C
169E4N
169Y3X
16AH0R
16D7PF
16EMJ6
16HTJ0
16KLKX
18123-05 CATARACT BOWERS INNOVATIVE EYE SURGERY C
380655118641 H5301ALCON1CPAK10
Lot Numbers:
15W2MK
15W46V
163YXV
165AX9
1687HH
169ACY
16C5FA
16CFV5
16E014
16HK94
16KET2
18208-09 CATARACT SUTTER FAIRFIELD SURG CTR
380651698956 H5301ALCON1CPAK10
Lot Numbers:
15UNTC
15VMU8
1603FR
161MXX
163RCJ
165830
167UJ3
168K5C
16C5KK
16DEPH
16E00D
16EW68
16JTXA
18382-04 DR GEORGE ZAMBELLI BEAVER VALLEY ASC
380655160596 H5301ALCON1CPAK10
Lot Numbers:
160CDC
163V3H
166N0T
16DXK0
16E002
167E55
18382-06 DR GEORGE ZAMBELLI BEAVER VALLEY ASC
380655169438 H5301ALCON1CPAK10
Lot Number:
16HLNK
18384-04 DR BURKS SPRINGHILL SURGERY CENTER
380651691520 H5301ALCON1CPAK10
Lot Numbers:
15XD8P
15XHEP
160CD8
160KCX
1632XR
JZ5188094
1646PR
JZ5189592
JZ5190276
JZ5196577
JZ5197432
JZ5200319
JZ5201138
JZ5203349
JZ5205873
18401-04 MCGRAW SIGHTPATH MEDICAL
380655146927 H5301ALCON1CPAK10
Lot Numbers:
160XR6
162LUU
167T95
168XD1
16AKE4
16E0YF
16EFA9
16EH0N
16H048
16KEUR
18406-03 DR KUCHINKA HAYWARD AREA HOSP
380651686441 H5301ALCON1CPAK10
Lot Numbers:
1673TW
1673U4
167TAT
168EJP
168K52
16HPXM
16JLKT
18427-07 CATARACT V A HOSPITAL
380651699038 H5301ALCON1CPAK10
Lot Numbers:
15VP93
16406W
167MUN
167VJH
168K62
18427-08 CATARACT V A HOSPITAL
380655168370 H5301ALCON1CPAK10
Lot Numbers:
16DYYE
16F3F6
16J3TA
18431-06 VISION EYE SC VISION EYE SURGERY CENTER
380651662506 H5301ALCON1CPAK10
Lot Numbers:
15V6U8
15WAN9
16591E
167E55
167XDC
1694T6
169YF2
16ACKW
16JA61
18445-03 K LEE/LIN CALIFORNIA PACIFIC MED CT
380655156568 H5301ALCON1CPAK10
Lot Numbers:
15V01H
15V01J
168LLX
18550-04 DR HU TORRES CAT & LSR CNTRL
380655151518 H5302ALCON2CPAK20
Lot Numbers:
1655ER
168K5N
16DJ3U
18555-04 DR WU - CENTURION CAT & LSR CNTRL
380655152751 H5302ALCON2CPAK20
Lot Numbers:
15WTXL
161HRN
JZ5187444
JZ5188106
18636-10 CATARACT BONNER GENERAL HOSPITAL
380651688094 H5301ALCON1CPAK10
Lot Numbers:
15VH4U
15X0W9
160YLK
16336T
166DR4
16915J
16C250
16ERF0
16HFK2
18649-05 NEASC CATARACT NORTHEAST ALIANCE SURG
380655165393 H5301ALCON1CPAK10
Lot Numbers:
168XDY
16C5HN
18685-06 CATARACT PAK CHRISTUS SANTA ROSA ASC
380655154397 H5301ALCON1CPAK10
Lot Numbers:
15X59N
1610M1
162789
164XYP
16A4XJ
16D16V
16ELKD
16KKDA
18873-06 CENTURION PROUET LAFAYETTE SURGICAL SPEC
380655132166 H5301ALCON1CPAK10
Lot Numbers:
15VEP8
16DJ2F
16JCAK
18888-04 SMITH EYE SURGERY CENTER OF ELIZABET
380655160107 H5301ALCON1CPAK10
Lot Numbers:
15W84F
15Y3R1
164LKJ
1687PV
16AHPY
16EMDM
16KAAM
18889-01 PROCTOR EYE SURGERY CENTER OF ELIZABET
380651669529 H5301ALCON1CPAK10
Lot Numbers:
15Y6XR
1616LM
168AUJ
168AUM
168CTN
16CW7X
16EP34
18907-02 CATARACT THE EYE SURGERY CENTER
380655127407 H5301ALCON1CPAK10
Lot Numbers:
15W6ER
15W6U6
15YM22
1612VD
163KRK
163KRM
164MD1
164MED
16846H
16846R
1697FE
169M1X
16ARW4
16FUY5
16HDPC
16HE7U
18911-02 MASON CATARACT THE ASC AT UNITED MEDICAL
380651691940 H5301ALCON1CPAK10
Lot Numbers:
167MRE
167X9F
16903L
16A801
16DJ28
16HLNN
16JEMY
18912-02 RHEE CATARACT THE ASC AT UNITED MEDICAL
380655138557 H5301ALCON1CPAK10
Lot Numbers:
15YN5T
JZ5188135
JZ5188885
JZ5189375
16JNAL
16KKC4
18915-02 PETRIE PACK THE ASC AT UNITED MEDICAL PA
380651691964 H5301ALCON1CPAK10
Lot Numbers:
15W8EL
15YTLW
162WVP
168K5D
16A80F
16DL1E
16HK2N
16JCAD
18918-03 DR SIMMONS CENTER FOR AMB SURGERY
380655153147 H5301ALCON1CPAK10
Lot Numbers:
JZ5181868
JZ5182649
JZ5184480
JZ5185579
161KHH
JZ5188136
JZ5197201
16CW8A
JZ5199160
JZ5203052
JZ5203702
16J2FX
18942-03 CENTURION PAK BAPTIST BEAUMONT SURG AFFI
380651692855 H5301ALCON1CPAK10
Lot Numbers:
15UUX9
15YTM3
1689JT
19050-03 DR CARTER GRAND VALLEY SURGICAL CENTER
380655139776 H5301ALCON1CPAK10
Lot Numbers:
15VCP0
15YTLT
162LVL
164TWE
168X60
16A24U
16AAMC
16CD88
16HMXR
16KMUY
19115-05 DR HUFFMAN AND WEST CUMBERLAND VALLEY SU
380655115169 H5301ALCON1CPAK10
Lot Numbers:
15WC64
160M20
163YYW
19184-05 DR KEIL PAK KEIL LASIK VISION CENTER
380655160725 H5301ALCON1CPAK10
Lot Numbers:
16717F
16851P
16JEMT
16KNXJ
19346-02 HUFFMAN/WEST LAKE CUMBERLAND
380655134474 H5301ALCON1CPAK10
Lot Numbers:
15VMPW
1612RR
1687PF
1687UY
16DPP1
16ERF4
16HXYR
16KKLK
19353-01 ECHOLS HAMILTON EYE INSTITUTE
380655135372 H5301ALCON1CPAK10
Lot Numbers:
15UWHY
15XLPE
165YRY
1693MF
16HMTL
16HV8R
16K87K
16KMPK
16KTD0
19407-06 CATARACT V A MEDICAL CENTER #637
380655147047 H5301ALCON1CPAK10
Lot Numbers:
160H5X
161WNR
19407-07 CATARACT V A MEDICAL CENTER #637
380655163467 H5301ALCON1CPAK10
Lot Numbers:
161KK8
164VKU
1654YX
168CXC
19408-02 MCMINNVILLE CATARACT MCMINNVILLE SURGERY
380655148679 H5301ALCON1CPAK10
Lot Numbers:
15WWJ2
15Y6XC
160RPC
161MX7
JZ5187463
JZ5187461
JZ5188168
JZ5189392
164LNT
16HDRJ
16HHP1
16KLJV
16KNXA
19409-06 LEXINGTON CATARACT LEXINGTON MED CTR
380655154588 H5301ALCON1CPAK10
Lot Numbers:
15XDA4
16198N
1682PR
168F5W
168XCP
16ANW8
16D7PY
16ENDP
16HLWX
16JWYT
19501-03 HAIDER EYE SURGERY CENTER OF ELIZABET
380655153673 H5302ALCON2CPAK20
Lot Number:
1603EE
19515-05 CHATTERJEE THE EYE SURGERY CENTER
380655160848 H5301ALCON1CPAK10
Lot Numbers:
160YNA
164VL9
1686E5
168LLY
16A84R
16H087
16HLX8
16KH4P
19533-02 DR COCO RUTLAND REG MED CTR
380655166130 H5301ALCON1CPAK10
Lot Numbers:
16AAMX
16K4TA
19554-02 DR NIESPODZANY BAY EYE SURGERY CENTER
380655161036 H5301ALCON1CPAK10
Lot Numbers:
15XVE1
164HH4
164NV8
16858C
16AAMP
16EK7M
16KEUD
19628-01 BASTOS KINGS DAUGHTERS HOSPITAL
380655159729 H5301ALCON1CPAK10
Lot Numbers:
15UXCE
162CNP
16F595
19677-01 CATARACT IOR ADVANCED LASER & CATARACT
380655163535 H5302ALCON2CPAK20
Lot Numbers:
161N3F
167ADJ
19729-01 DR DICKES OPHTHALMOLOGY LTD
380655166505 H5302ALCON2CPAK20
Lot Numbers:
1694RD
16ANV3
16CTV6
19729-05 DR DICKES OPHTHALMOLOGY LTD
380655169698 H5302ALCON2CPAK20
Lot Numbers:
16EH0E
16FF6H
16FJYY
16H2XX
19746-01 DR LEALE PAK LAWRENCE COUNTY SURGERY CTR
380655166666 H5301ALCON1CPAK10
Lot Numbers:
16A303
16A4W8
16AAL8
16EK2U
19770-01 DR. BADER CAT PAK SW LINCOLN SURGERY CEN
380655167595 H5301ALCON1CPAK10
Lot Number:
16A4XA
19787-01 DR BORDEWYK OPHTHALMOLOGY LTD
380655170281 H5302ALCON2CPAK20
Lot Number:
16H04F
19821-02 DR KROLL CLARKSVILLE EYE SURGERY CENTER
380655171066 H5301ALCON1CPAK10
Lot Numbers:
16F3K0
16J852
16K6K9
19830-01 HAIDER CCMH CORPORATION
380655172902 H5301ALCON1CPAK10
Lot Number:
16K2CD
3316-33 CATARACT V A MEDICAL CENTER
380655115497 H5301ALCON1CPAK10
Lot Numbers:
15V4RE
15WTV7
16444N
167LNM
16898C
16A551
16AKL6
3316-35 CATARACT V A MEDICAL CENTER
380655167830 H5301ALCON1CPAK10
Lot Numbers:
16ELTX
16K8RT
3434-49 CATARACT SKIFF MED CTR
380655159941 H5301ALCON1CPAK10
Lot Number:
15YJT9
3434-50 TURNER CATARACT SKIFF MED CTR
380655169490 H5301ALCON1CPAK10
Lot Number:
16EUWT
4331-32 CATARACT CATARACT
380653344967 H5301ALCON1CPAK10
Lot Numbers:
15WTTU
160NNC
166A9F
166YKF
1687FX
169FDU
16ECTK
16EUVM
16HTH9
16KFYD
16KP13
4520-22 OPHTHALMIC COLISEUM SAME DAY SURG
380653398960 H5301ALCON1CPAK10
Lot Numbers:
JZ5179661
16KMX9
4937-35 CATARACT ASHTABULA MED CTR
380651698598 H5301ALCON1CPAK10
Lot Numbers:
15V51V
160VUX
162LT4
164PYX
166DRC
168CV1
168K55
169J47
16ACFK
16DC7Y
16HFHD
16JJ7M
5322-68 CATARACT SURGICENTER OF PALO ALTO
380655149300 H5301ALCON1CPAK10
Lot Numbers:
15UV37
15UWDT
15VUPD
15YE38
JZ5187250
JZ5187254
JZ5187252
JZ5187535
JZ5194773
JZ5187539
162V35
162Y5N
JZ5194775
16A2JP
16AAM9
16D6WV
JZ5198788
JZ5198790
16E2R2
16ECU8
16J2F9
JZ5203407
16JA9F
16KT7H
6274-17 ST ANTHONY CATARACT PACK ST ANTHONY HOSP
380655170168 H5301ALCON1CPAK10
Lot Number:
16HPYM
6839-25 RICHARDSON COL HOSP GEORGETOWN
380655120323 H5301ALCON1CPAK10
Lot Numbers:
15V679
16063E
16372L
164NV3
1677CD
16828X
169NJW
16AYLX
16DVKR
6839-26 RICHARDSON COL HOSP GEORGETOWN
380655170090 H5301ALCON1CPAK10
Lot Numbers:
16EMK2
16KD1L
8189-69 CATARACT INLAND EYE CLINIC
380653416602 H5301ALCON1CPAK10
Lot Numbers:
15VAKN
15WTTM
15Y57L
15YK9A
160LUK
161WHR
162V2M
163KTE
16438L
165MVL
165N6C
16678Y
167P6C
168DA3
JZ5193835
JZ5193833
JZ5193963
JZ5193965
JZ5195241
16D18R
16D192
JZ5199823
JZ5202171
JZ5202167
JZ5202169
16JJ7U
JZ5205279
8722-34 PHACO EMORY CLINIC INC
380655138588 H5301ALCON1CPAK10
Lot Numbers:
160LXM
JZ5186195
JZ5188228
JZ5188804
JZ5202209
JZ5203955
9385-44 DR CAMPAGNA S TX REGIONAL MED CTR
380651675681 H5301ALCON1CPAK10
Lot Numbers:
JZ5184199
1611XY
JZ5188421
1689P6
9385-47 CATARACT METHODIST HOSPITAL SOUTH
380655167755 H5302ALCON2CPAK20
Lot Numbers:
16DR44
16E3K8
16FCAF
16FU61
9931-69 OPHTHALMIC JONES MEM HOSP
380655122655 H5301ALCON1CPAK10
Lot Numbers:
JZ5180065
JZ5180595
JZ5182223
JZ5187142
JZ5188249
JZ5189472
JZ5194262
16E1JL
16EJ4M
16H7CW
9931-70 OPHTHALMIC JONES MEM HOSP
380655168653 H5301ALCON1CPAK10
Lot Numbers:
JZ5201780
JZ5202701
JZ5203662
AS0720-75 CDN-CATARACT PACK HIGH RIVER HOSPITAL
380655158968 No UDI - Foreign Pak
Lot Numbers:
15Y51E
15Y6X6
15Y6XT
162RYH
16435M
164NVP
1682R2
168E4U
169T10
169TW8
16ARF3
16AVW3
16D7PU
16D9L1
16EP2L
16FU8A
16HCFM
AS0720-76 CDN-CATARACT PACK HIGH RIVER HOSPITAL
380655172193 No UDI - Foreign Pak
Lot Number:
16J57N
AS10104-15 CDN-CATARACT CENTURION WHITEHORSE GH
380655142578 No UDI - Foreign Pak
Lot Numbers:
15YCEA
160KCK
164LEC
16ALMT
16CWL1
16H49A
AS12593-09 NZ-DR WILSON CATARACT TAIRAWHITI DISTRIC
380655166970 No UDI - Foreign Pak
Lot Numbers:
16A7K0
16AW7E
16DVFL
16EXY2
AS13781-13 CDN-MSJ CATARACT CENTURION VHC
380651691124 No UDI - Foreign Pak
Lot Numbers:
15V1CY
15V7D8
15V7WC
15Y512
15Y56Y
15YDLM
15YDLW
162LUD
1630VL
1630VM
1630WD
1630XN
163372
165MRL
165MT5
16629M
16629R
166KP4
168E4E
168EJ5
168EJU
168EK3
168F5Y
168R5V
16929W
1693LV
169VHH
169Y98
169Y9J
169YA2
169YV0
16A9JK
16A9LA
16AALH
16ATRW
16ATT7
16C93A
16CCHM
16DCCU
16DCFU
16DD1D
16DF38
AS13781-14 CDN-MSJ CATARACT CENTURION VHC
380655169407 No UDI - Foreign Pak
Lot Numbers:
16FT7Y
16H5FE
AS13781-15 CDN-MSJ CATARACT CENTURION VHC
380655172766 No UDI - Foreign Pak
Lot Numbers:
16K3KU
16K3LT
16K3LU
16K3LW
16K3LV
AS13783-04 CDN-MSJ CATARACT TIPLESS
380653174076 No UDI - Foreign Pak
Lot Numbers:
15Y6YA
15YCE4
16372N
16435H
166V6X
AS15524-09 CDN-CATARACT CENTURION ALCON PASQUA HOSP
380655130162 No UDI - Foreign Pak
Lot Numbers:
15UNU7
15V7VW
15V7WE
15V8CR
15VKVX
15WDNN
15WDRF
160082
1612RF
1612T4
1612TJ
1612TK
16353L
16353W
1641VN
164LLW
164LR6
1677ET
167JWA
167MNV
167VXC
167VY6
168F54
168J0F
169Y50
169Y6N
16A0T4
16A9JY
16A9KT
16A9LC
16ALRL
16AVWF
16CYTA
16EE16
16EE1U
16EE3A
16EF2T
16EF3L
16EK3D
16F03V
16F03Y
16HV97
16HV9J
16JR1M
16K4UC
16K3M9
16KH3A
16KJN4
16KMP4
16KMP9
16KMR4
AS17055-06 CDN-CATARACT CENTURION WEYBURN GH
380655157091 No UDI - Foreign Pak
Lot Numbers:
15X5AE
16009X
167T8W
16A30T
16CFJA
16CK1H
16EKWT
16FPJH
AS17612-04 AUS-DR HARRISBERG PHACO PAK BONDI JUNCTI
380655137833 No UDI - Foreign Pak
Lot Numbers:
15VHD9
15YCE7
162Y51
1689L2
16DU4M
16F3H5
16H1HX
16J9TX
AS18319-05 CDN-COMBO RETINAL PACK COMBO VANCOUVER
380655164549 No UDI - Foreign Pak
Lot Number:
16ELTN
AS18842-02 CDN-MSJ CENTURION LMD VANCOUVER
380651692527 No UDI - Foreign Pak
Lot Numbers:
15UYW2
15YCVE
15YE2F
162RYX
162T03
1630VV
164A31
164MFR
165MTP
1677CF
167F6M
168LC0
168LCW
1697HV
16A84M
16A85K
16AYJ8
16DC97
16DCFR
16ELJL
16FA76
16HHPL
16HMUL
16HPXT
16JWXM
AS19775-01 NZ-SX N PLYMOUTH CATARACT SX NEW PLYMOUT
380655167700 No UDI - Foreign Pak
Lot Numbers:
16AYK6
16AYKP
16KD03
AS5894-31 CDN-CATARACT CENTURION 2.4 MILLS MH
380655155684 No UDI - Foreign Pak
Lot Numbers:
15YC61
1610MK
1610P9
164A4H
167MNT
16A6MM
16A9K0
16A9K4
16AKF8
16ARH0
16EF3A
AS5966-23 CDN-CATARACT CENTURION DELTA HOSPITAL
380651700451 No UDI - Foreign Pak
Lot Numbers:
15VJL8
161VPA
161WD2
164EPR
1657K1
1683V3
16ARHU
16CD8D
16E4C5
16FU83
AS5966-24 CDN-CATARACT CENTURION DELTA HOSPITAL
380655172230 No UDI - Foreign Pak
Lot Number:
16JTXP
QNS39257B DR DEROSE VALLEY EYE SURGICAL CTR
Non Sterile H5301ALCON1CPAK10
Lot Number:
16JL5D
QNS39259A AHDIEH/CHERFAS/PEET VALLEY EYE SURGICAL
Non Sterile H5301ALCON1CPAK10
Lot Number:
16JL5E
|
Recalling Firm/ Manufacturer |
Alcon Research, LLC 9965 Buffalo Speedway Houston TX 77054-1309
|
For Additional Information Contact |
Kristen Kellerhals 817-661-4047
|
Manufacturer Reason for Recall |
Due to complaints of particulates, residue, occlusions, and bent tips for sterile cannulas.
|
FDA Determined Cause 2 |
Under Investigation by firm |
Action |
On 03/15/2024, the firm sent an "URGENT: VOLUNTARY MEDICAL DEVICE FIELD CORRECTION" Letter via FedEx overnight to inform customer that, specific lots of Alcon Custom Pak containing Oasis Medical 27G Chang Hydrodissection Cannulas. Alcon has received customer complaints for foreign material, occlusions and bent tips for these cannulas. We are asking that you remove and dispose of the included 27G Chang Hydrodissection Cannula upon opening your Custom Pak for its specific surgical case.
Customer are to take the following actions:
1. See Table 1 for list of affected Alcon Custom Pak lots that were distributed to their facility. They may have received Custom Pak lots assembled prior to this Field Correction notification, and as a result, they may be receiving affected inventory in future shipments. Any affected Alcon Custom Pak in the future, will be identified by a sticker and reads, "URGENT FIELD CORRECTION Discard enclosed 27G Chang Hydrodissection Cannula"
2. Review their inventory of Alcon Custom Pak lots against the lots listed in Table 1. For affected lots in their current on-hand inventory, affix the provided stickers directly to the outside of their affected Custom Pak in a location most easily seen. NOTE: Alcon Custom Pak units are sterile and should not be opened prior to surgery.
3. Upon opening of the identified Alcon Custom Pak for surgical use, remove and dispose of the enclosed 27G Chang Hydrodissection Cannula.
4. Use a separate sterile standalone hydrodissection cannula, either from their own inventory or those supplied by Alcon. For impacted products that will ship in the future, Alcon is planning to ship sterile stand-alone substitutions. Call Alcon Customer Service (1-800-862-5266) if help it needed in obtaining replacement sterile standalone hydrodissection cannulas.
5. Keep Table 1 for their records should they receive any affected Alcon Custom Pak lots in the near future.
Questions/concerns, contact Alcon Customer Service at 1-800-862-5266.
|
Quantity in Commerce |
57,352 cannulas |
Distribution |
Worldwide distribution - U.S. Nationwide including in the states of AK, AR, CA, CO, CT, FL, GA, IA, ID, IL, IN, KY, LA, MA, MD, MI, MN, MT, NC, ND, NE, NJ, NY, OH, OK, OR, PA, SC, SD, TN, TX, UT, VA, WA, WI, and WV. The countries of Australia, Canada, and New Zealand. |
Total Product Life Cycle |
TPLC Device Report
|
|
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
|
510(K) Database |
510(K)s with Product Code = LRO and Original Applicant = ALCON LABORATORIES
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