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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device strabismus detection device
Definition For the automated detection of misalignment of the visual axes for prescription use only.
Product CodePMW
Regulation Number 886.1342
Device Class 2

MDR Year MDR Reports MDR Events
2024 9 9

Device Problems MDRs with this Device Problem Events in those MDRs
Premature Discharge of Battery 9 9

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 9 9

Recalls
Manufacturer Recall Class Date Posted
1 Rebiscan, Inc. II Nov-01-2022
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