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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device accessories, soft lens products
Regulation Description Soft (hydrophilic) contact lens care products.
Product CodeLPN
Regulation Number 886.5928
Device Class 2


Premarket Reviews
ManufacturerDecision
ALCON
  SUBSTANTIALLY EQUIVALENT 2
ALCON RESEARCH, LTD.
  SUBSTANTIALLY EQUIVALENT 2
BAUSCH & LOMB, INC.
  SUBSTANTIALLY EQUIVALENT 2
OPTICS LABORATORY, INC.
  SUBSTANTIALLY EQUIVALENT 1

Device Problems
Product Quality Problem 2873
Adverse Event Without Identified Device or Use Problem 162
Device Operates Differently Than Expected 24
Use of Device Problem 13
Device Markings / Labelling Problem 12
Improper or Incorrect Procedure or Method 8
Contamination During Use 7
Appropriate Term/Code Not Available 6
Insufficient Information 6
Leak / Splash 6
No Apparent Adverse Event 5
Contact Lens 5
Device Contamination with Chemical or Other Material 4
Device Emits Odor 3
Crack 3
Device Expiration Issue 3
Contamination / decontamination Problem 3
Unexpected Therapeutic Results 3
Incomplete or Missing Packaging 2
Device Handling Problem 1
Failure to Obtain Sample 1
Pumping Stopped 1
Microbial Contamination of Device 1
Inadequate Instructions for Non-Healthcare Professional 1
Naturally Worn 1
Fungus in Device Environment 1
Difficult to Remove 1
Patient-Device Incompatibility 1
Degraded 1
Total Device Problems 3158

Recalls
Manufacturer Recall Class Date Posted
1 Bausch & Lomb Inc Irb II Nov-21-2016

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