openFDA Device Enforcement
Report-date coverage
June 20, 2012–July 08, 2026
Known gap: openFDA describes 2004-present coverage, but the current export has no report-date records in this interval.
openFDA Device Recall
event_date_initiated coverage
June 01, 1997–June 30, 2026
Enforcement coverage uses report dates; product initiation dates can precede those bounds. Device-enrichment coverage uses FDA event_date_initiated.
Product dates, classifications, firms, and source wording remain attached to their individual rows.
Opening this dossier never hides products that did not match a prior timeline filter.
device · product 1 of 4
Synergetics I Pack Injection Kit- Tray for use with Ophthalmic injections Model/Catalog Number: 18060
Could not confirm products were exposed to the proper sterilization cycle can potentially cause post operative wound infection or injection site infection.
These labels are deterministic app interpretations, not FDA categories.
Official device-enrichment evidence · Sourced
Release of Material/Component prior to receiving test results
Could not confirm products were exposed to the proper sterilization cycle can potentially cause post operative wound infection or injection site infection.
Code information
UDI: 10841305101064 LOT: P62764979R
Distribution pattern
MO
device · product 2 of 4
Synergetics I-Pack Injection Kit with Drape -For use with Ophthalmic injections Model/Catalog Number: 18061
Could not confirm products were exposed to the proper sterilization cycle can potentially cause post operative wound infection or injection site infection.
These labels are deterministic app interpretations, not FDA categories.
Official device-enrichment evidence · Sourced
Release of Material/Component prior to receiving test results
Could not confirm products were exposed to the proper sterilization cycle can potentially cause post operative wound infection or injection site infection.
Code information
UDI: 10841305101071 LOT: P63044983R
Distribution pattern
MO
device · product 3 of 4
Synergetics I Pack Injection Kit Custom-Tray for use with Ophthalmic injections Model/Catalog Number: 18069 Product Description:
Could not confirm products were exposed to the proper sterilization cycle can potentially cause post operative wound infection or injection site infection.
These labels are deterministic app interpretations, not FDA categories.
Official device-enrichment evidence · Sourced
Release of Material/Component prior to receiving test results
Could not confirm products were exposed to the proper sterilization cycle can potentially cause post operative wound infection or injection site infection.
Code information
UDI 10841305101125 LOT: P62764965R
Distribution pattern
MO
device · product 4 of 4
Synergetics I Pack Injection Kit with Wire Speculum- Tray for use in Opthalmic Injection Model/Catalog Number: 18069W
Could not confirm products were exposed to the proper sterilization cycle can potentially cause post operative wound infection or injection site infection.
These labels are deterministic app interpretations, not FDA categories.
Official device-enrichment evidence · Sourced
Release of Material/Component prior to receiving test results
Could not confirm products were exposed to the proper sterilization cycle can potentially cause post operative wound infection or injection site infection.
