FEI 1317628
Bausch & Lomb Incorporated
1400 North Goodman Street, Rochester, NY, US
MDR events4,531All time
Recalls2All time
Registered products205
Establishment typeComplaintComplaint File Establishment per 21 CFR 820.198
Registered product codes
205 product codes
Recent MDR events
4,531 on file
- ENVISTA EEJul 16, 2026InjuryMW5190815
- ULTRA FOR PRESBYOPIA CONTACTLENSMay 14, 2026Injury0001313525-2026-00051
- ULTRA (SAMFILCON A) CONTACT LENSApr 10, 2026Injury0001313525-2026-00028
- CLEAR CARE CLEANING & DISINFECTING SOLUTIONApr 8, 2026InjuryMW5186458
- CLEAR CARE CLEANING & DISINFECTING SOLUTIONApr 8, 2026InjuryMW5186459
- ENVISTA EE 13.5 DIOPTERApr 6, 2026MalfunctionMW5186384
- BAUSCH + LOMB ULTRA FOR ASTIGMATISM MONTHLY CONTACT LENSES FOR ASTIGMATISMApr 6, 2026OtherMW5186411
- ULTRA FOR PRESBYOPIA CONTACTLENSMar 17, 2026Injury0001313525-2026-00016
- ULTRA FOR PRESBYOPIA CONTACTLENSMar 17, 2026Injury0001313525-2026-00015
- B&L LI61AOFeb 12, 2026InjuryMW5183730
Recalls
2 on file
- TerminatedOct 15, 2003
The firm's DP8200 Microflow Needle Packs were labeled with the firm's DP8115 Phaco Needle Packs and visa versa.
View FDA record ↗ - TerminatedOct 15, 2003
The firm's DP8200 Microflow Needle Packs were labeled with the firm's DP8115 Phaco Needle Packs and visa versa.
View FDA record ↗
Compliance history
Matched by FEI 1317628.
FDA inspections
1 on file
- No Action Indicated (NAI)Sep 9, 2024
Bioresearch Monitoring
Inspection citations
0 on file
No citations on file for this FEI number.
Compliance actions
0 on file
No warning letters or injunctions on file for this FEI number.
Import refusals
2 on file
Top refusal reasons
Compare to industry ↗- Division of Southwest Imports (DSWI)Jun 2, 2026
86LPL \ LENSES, SOFT CONTACT, DAILY WEAR
- Division of Southeast Imports (DSEI)Apr 2, 2025
86LPM \ LENSES, SOFT CONTACT, EXTENDED WEAR