10 results
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6ms
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Sources: EU EUDAMED, US FDA
CATARACT PACK- OJOS INC.- (1) TABLE COVER REINF. 44" X 78" L/F (2) MEDICINE CUP 1oz. (2) ABSORBENT TOWEL 15" X 20" LIF (1 0) EYE SPEAR MICRO SPONGE (1) EYE PAD 2 1/8 X 2 5/8 LIF (4) DRAPE UTILITY LIF (1) EYE SHIELD UNIVERSAL (2) GOWN LGE STANDARD SMS VELCRO/NECK (1) MAYO STAND COVER REINF. LIF (1) EYE DRAPE LIF (1) SYRINGE 3cc W/0 NDL L/LOCK LIF (1) WIPE INSTRUMENT 1MM L/F EO sterilized surgical convenient packs packaged into polyester/polyethylene breather bag with Tyvek double vents.
FDA Enforcement
Class I
·Terminated·Customed, Inc·September 10, 2014
PHACO PACK - (10) GAUZE SPONGE 4" X 4" 12PLY (2) SYRINGE 3cc W/NDL. 21G X 1 %" (2) MEDICINE CUP 2 oz. (1) OPHTHALMIC DRAPE W/POUCH (1) GOWN STANDARD LGE.SMS (1) GOWN NON REINF. Lge. T/Wrap SMS (1) EYE SHIELD UNIVERSAL (1) TABLE COVER 44" X 90" (1) MAYO STAND COVER REINF. LIF (3) ABSORBENT TOWEL 15" x 20 LIF (2) EYE PAD 2 1/8 X 2 5/8 LIF (1 0) EYE SPEAR MICRO SPONGE VELCRO/NECK EO sterilized surgical convenient packs packaged into polyester/polyethylene breather bag with Tyvek double vents.
FDA Enforcement
Class I
·Terminated·Customed, Inc·September 10, 2014
OPHTALMIC PACK - (1) GOWN LGE SMS NON REINF TIWRAP (1) IODINE POVIDONE 1oz. (2) TOWEL ABSORBENT 15" x 20" UF (1) SYRINGE 3cc W/NEEDLE 21 G X 1 Y. UF (6) COTION TIP APPLICATOR 6" WOOD (1) TABLE COVER REINFORCED 50" X 90" UF (1) PAD EYE 2 1/8 X 2 5/8 (1) CYSTOTOMO IRRIG. PEARCE 25G X 5/8 (1) SHIELD EYE UNIVERSAL (1) Pr. GLOVES SURG.# 7% LATEX (10) SPONGE EYE SPEAR MICRO (1) SYRINGE 1cc TUBER. 25G X 5/8 SITIP UF (10) GAUZE SPONGES 4" X 4" 12PL Y (1) Pr. GLOVES SURG. 8 POWDER LATEX (1) MAYO STAND COVER REINFORCED UF (1) BLADE 15D WITH HANDLE (STABKNIFE) (1) EYE DRAPE (1) GOWN LARGE STANDARD SMS (1) TRAY 3/COMPART (1) BAG ZIP LOCK (1) ANGLED FULL HANDLE (1 ) Pr. GLOVES SURGICAL# 6% LATEX EO sterilized surgical convenient packs packaged into polyester/polyethylene breather bag with Tyvek double vents.
FDA Enforcement
Class I
·Terminated·Customed, Inc·September 10, 2014
RETINA PACK - (1) TABLE COVER REINFORCED 44" X 78" LIF (50) COTTON TIP APPLICATOR 6" WOOD LIF (2) GOWN IMPERVIOUS EXTRA REINFORCED LARGE (2) MEDECINE CUP 2oz LIF (5) TOWELS ABSORBENT 15" X 20" LIF ( 1) UNIVERSAL EYE SHIELD (1) EYE DRAPE (1) BIPOLAR CABLE DISPOSABLE ( 1) OPHTALMIC BIPOLAR PENCIL (10) GAUZE SPONGE 4" X 4" 16PLY (2) EYE PAD 2 1/8 X 2 5/8 ST. ( 1) MAYO STAND COVER REINFORCED LIF ( 1) KNIFE 15 5.0 CONTROLLED DEPTH. (1) NEEDLE & BLADE COUNTER 20C FOAM/MAG LIF (1) SURGICAL BLADE #15 STAINLESS STEEL (3) SYRINGE 1CC TUBER. 25G X 5/8 SLIP TIP L/F EO sterilized surgical convenient packs packaged into polyester/polyethylene breather bag with Tyvek double vents.
FDA Enforcement
Class I
·Terminated·Customed, Inc·September 10, 2014
OPHTALMIC PACK- (1) TABLE COVER REINF. 44" X 78" UF (1) GOWN SMS XLGE STD UF (2) TOWEL ABSORBENT 15" X 20" LIF (1) SYRINGE 3cc W/0 NDL LILOCK UF (1) MAYO STAND COVER REINF. LIF (1) NEEDLE HYPODERMIC 18G X 1% ST. UF (10) EYE MICRO SPONGE UF (2) LABEL CONTRAST BLUE (1) GOWN LGE STD SMS (1) WIPE INSTRUMENT 1MM (1) EYE DRAPE UF (1) LABEL XYLOCAINE FOR MEDICATION YELLOW (1) IODINE POVIDONE 1oz. (1) EYE SHIELD UNIVERSAL L/F (10) APPLICATOR COTION 6" WOOD (1) BALANCED SALT SOLUTION 18ML LIF (10) GAUZE SPONGE 4" X 4" 12P Y UF (1) LABEL BSS (1) TRAY 3/COMPARTMENT LIF (1) LABEL EPINEPHRINE VIOLET/WHITE (1) LABEL IODINE WHITE/BLACK Product Usage: EO sterilized surgical convenient packs packaged into polyester/polyethylene breather bag with Tyvek double vents.
FDA Enforcement
Class I
·Terminated·Customed, Inc·September 10, 2014
OPHTALMIC PACK- (3) ABSORBENT TOWELS 15" X 20" LIF (1) MAYO STAND COVER REINFORCED LIF (1) OPHTALMIC DRAPE WITH POUCH LIF (2) SYRINGE 3cc WITHOUT NEEDLE LUER LOCK LIF (10) COTTON TIP APPLICATOR 6" WOOD (1) SYRINGE 10cc WITHOUT NEEDLE LUER LOCK LIF (2) NEEDLE HYPODERMIC 18G X 1 Y." (1) NEEDLE HYPODERMIC 25G X 5/8" (2) EYE PAD 2 1/8 X 2 5/8 UF (5) EYE SPEAR MICRO SPONGE (2) LITE GLOVE LIF (1) CABLE BIPOLAR (1) EYE SHIELD UNIVERSAL (1) OPHTALMIC PENCIL BIPOLAR (1) IV ADM. SET 15 DROPS 106" LONG L/F (1) TABLE COVER REINFORCED 50" X 90" UF (1) KNIFE/BLADE MIN. EDGE ROUND (1) KNIFE 15 5.0 CONTROLLED (1) PLASTIC TRAY 3/COMPARTMENT (1)KNIFE 3.2MM ANGLE BEVEL UP (1) CYSTOTOMO IRRIG. 25GA X5/8 (1) MAYO TRAY LARGE (2) GOWN STANDARD LARGE SMS STD VELCRO NECK (1) PVP PAINT 8" STICK SPONGE (1) NEEDLE & BLADE COUNTER 30c MAG/MAG/LF EO sterilized surgical convenient packs packaged into polyester/polyethylene breather bag with Tyvek double vents
FDA Enforcement
Class I
·Terminated·Customed, Inc·September 10, 2014
PREMIUM OPHTHALMIC PACK- CUSTOMED- (1) GOWN SMS X-LARGE STD RAGLAN (1) CUP MEDICINE 2oz (1) DRAPE OPHTHAL. WITH POUCH LIF (1 0) SPONGE EYE SPEAR MICRO (1) SHIELD EYE UNIVERSAL (6) COTTON TIP APPLICATION 6" WOOD LIF (1 0) GAUZE SPONGES 4"X 4" 12PL Y (2) TOWELS ABSORBENT 15" x 20" LIF (1) COVER MAYO STAND REINFORCED LIF (1) SYRINGE 1 ML WITHOUT NEEDLE LUER LOCK LIF (1) COVER TABLE REINFORCED 50" x 90" LIF (1) SYRINGE 3cc WITH NEEDLE 21 G X 1 % LIF (1) GOWN LARGE SMS NON REINFORCED TOWEL/WRAP EO sterilized surgical convenient packs packaged into polyester/polyethylene breather bag with Tyvek double vents.
FDA Enforcement
Class I
·Terminated·Customed, Inc·September 10, 2014
Expansion of previous recall of AcrySof IQ ReSTOR and AcrySof IQ ReSTOR Toric IOL; now to include AcrySof IQ Toric models SN6AT6, SN6AT7, SN6AT8, and SN6AT9. Intended for primary implantation in the capsular bag of the eye for visual correction.
FDA Enforcement
Class I
·Terminated·Alcon Research, Ltd.·December 2, 2015
Viscocel and Viscocel Plus. These products are intraocular fluid devices consisting of non-gaseous fluid intended to be introduced into the eye to aid performance of surgery, such as to maintain anterior chamber depth, preserve tissue integrity, protect tissue from surgical trauma, or function as a tamponade during retinal reattachment.
FDA Enforcement
Class I
·Terminated·C.L.R. Medicals International, Inc.·January 1, 2014
UMBILICAL VESSEL CATHETER KIT - CUSTOMED- (1) PAPER TAPE MEASURE DISP. 24" (1) FENESTRATED DRAPE 18" x 26" LIF (1) NEEDLE HOLDER BAUMGARTNER 5" (2) HALSTED MOSQUITO CVD 5" SERRAT (1) ADSON FORCEP TISS. Wff (1) SYRINGE 3cc WITHOUT NEEDLE LUER LOCK LIF (6) GAUZE SPONGE 2" X 2" 8PL Y (6) GAUZE 4" X 4" 16PL Y (1) SYRINGE 1 cc TB SffiP (1) IRIS FORCEP SERR Y. CVD 4" WITH PROTECTOR TIP (1) NEEDLE WITH FILTER 18 X 1 Y. BLUNTffiP (1) SUTURE 3-0 BLK MONOFIL (1) TRAY ORGANIZER FULL DEEP (1) WRAPPER 30" X 30" L/F (1) PVP TRIPLE IODOPHOR SWABSTICK (1) TONGUE DEPRESSOR 6" WOOD (1) IRIS SCISSOR STRAIGHT 4 Y. W/PROTECTOR TIP (1) SCALPEL WITH HANDLE #11 (1) MOSQUITO FORCEP STRAIGHT 5" (2) SYRINGE 5cc WITHOUT NEEDLE LUER LOCK LIF (2) 3 PLY POLY TOWEL (1) UMBILICAL TAPE (1 ) PROBE GRONED & DISNEETNS 6" 2ML (1) EYE DRESSING EXT FINE POINT FULL (2) NEEDLE WITH FILTER 18 X 1 Y. NOKOR PO (1) PLASTIC TRAY 2/COMPARTMENT (1) HALF TRAY (1) STOPCOCK 3 WAY LUER SLIP EO sterilized surgical convenient packs packaged into polyester/polyethylene breather bag with Tyvek double vents.
FDA Enforcement
Class I
·Terminated·Customed, Inc·September 10, 2014