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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device folders and injectors, intraocular lens (iol)
Regulation Description Intraocular lens guide.
Product CodeMSS
Regulation Number 886.4300
Device Class 1


Premarket Reviews
ManufacturerDecision
ALCON
  SUBSTANTIALLY EQUIVALENT 3
ASICO LLC
  SUBSTANTIALLY EQUIVALENT 2
BAUSCH & LOMB, INC.
  SUBSTANTIALLY EQUIVALENT 9
DUCKWORTH & KENT, LTD.
  SUBSTANTIALLY EQUIVALENT 3
HOYA SURGICAL OPTICS, INC.
  SUBSTANTIALLY EQUIVALENT 1
LENSTEC, INC.
  SUBSTANTIALLY EQUIVALENT 4
PHARMACIA & UPJOHN CO.
  SUBSTANTIALLY EQUIVALENT 1
RAYNER
  SUBSTANTIALLY EQUIVALENT 7
SIS LTD. SURGICAL INSTRUMENT SYSTEMS
  SUBSTANTIALLY EQUIVALENT 1
STAAR
  SUBSTANTIALLY EQUIVALENT 5

Device Problems
No Known Device Problem 554
Haptic(s), bent 177
Lens (IOL), torn, split, cracked 157
Lens Damaged in Delivery System 129
Other (for use when an appropriate device code cannot be identified) 122
Plunger Override 109
Haptic Damaged in Delivery System 101
Haptic(s), broken 59
Lens, damaged by cartridge 43
Failure to deliver 41
Use of Device Issue 29
Lens Stuck in Delivery System 28
Lens, stuck in cartridge 20
Haptic, Kinked 19
No Information 16
No code available 14
Torn material 12
Deployment issue 11
Bent 10
Difficult to insert 9
Detachment of device component 8
Split 8
Lens (IOL), scratch, mark on 7
Break 7
Delivered as unsterile product 7
Mechanical jam 7
Delivery System Issue, No Description 6
Device handling issue 6
Unknown (for use when the device problem is not known) 6
Lens, difficulty loading into cartridge 6
Inaccurate delivery 6
Haptic, Missing 5
Delivery system failure 5
Tears, rips, holes in device, device material 5
Particulates 5
Lens, malposition of 4
Haptic Stuck in Delivery System 4
Device Issue 4
Lens replacement 4
Failure to advance 3
Folding Issue 3
Defective item 3
Plunger Issue, No Description 3
Device operates differently than expected 3
Difficult to advance 3
Haptic(s), detached 3
Defective component 3
Sticking 2
Difficult to position 2
Crack 2
Expulsion 2
Foreign material present in device 2
Device or device component damaged by another device 2
Fitting problem 2
Sharp/jagged/rough/etched/scratched 1
Malposition of device 1
Lens (IOL), line, crease on 1
Malfunction 1
Detachment of device or device component 1
Material Protrusion 1
Nozzle Tip Issue, No Description 1
Failure to deploy 1
Explanted 1
Difficult to fold or unfold 1
Failure to fold 1
Foreign material 1
Component falling 1
Injector system failure, no infusion 1
Lens, opacification of 1
Lens, vaulting 1
Loose or intermittent connection 1
Mechanical issue 1
Mislabeled 1
Premature deployment 1
Device remains implanted 1
Material rigid or stiff 1
Material rupture 1
Material opacification 1
Kinked 1
Optical decentration 1
Wedge filter problem 1
Component missing 1
Packaging issue 1
Scratched material 1
Total Device Problems 1838

Recalls
  2007 2008 2009 2010 2011 2012 2013 2014 2015 2016
Class I 0 0 0 0 0 0 0 0 0 0
Class II 0 0 0 0 0 0 0 0 0 0
Class III 0 0 0 0 0 0 0 0 0 0


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