Skip to content
Print-ready dossier — use your browser's print dialog to save as PDF.

Bausch + Lomb

Model SP2-7550A · Bausch & Lomb Incorporated · DI 00757770403929

MMO — Tray, Surgical, Ent · Class I · 21 CFR 874.4420

UDILibrary device dossier · generated 2026-09-12 · sources: FDA GUDID, openFDA (recalls, MAUDE, 510(k)/PMA), FDA Data Dashboard (inspections, compliance actions), 510(k) summary documents.

Recall history (0)

No recalls linked in the loaded window.

Adverse-event reports — MAUDE (0)

Caveat (required reading): MAUDE report counts cannot be used to compute incidence rates or compare device safety. Reporting is incomplete, duplicated, and spikes with publicity; there is no denominator of devices in use. The peer line is a reporting baseline (average device in the same product code), not a risk measure.

24572019-09: 0 reports for this device; peer average 7/device09
Monthly adverse-event reports for this device versus the product-code average.
MonthThis device (reports)Product-code average (reports per device)
2019-0907
This device (reports/month)Average device in MMO (reports/device/month)

Regulatory clearances

  • None linked in the loaded window.

Manufacturer compliance record — Bausch & Lomb Incorporated

  • Warning Letter 2012-06-11 Valeant Amsterdam Logistics Center
  • NAI 2024-09-09 Bausch & Lomb Incorporated · 0 citations
  • NAI 2024-09-09 Bausch & Lomb Incorporated · 0 citations
  • NAI 2019-10-10 Bausch & Lomb, Inc. · 0 citations
  • NAI 2019-10-10 Bausch & Lomb, Inc. · 0 citations
  • NAI 2019-10-08 Bausch & Lomb Inc · 0 citations
  • NAI 2019-10-08 Bausch & Lomb Inc · 0 citations
  • NAI 2018-08-28 Bausch & Lomb Incorporated · 0 citations
  • NAI 2018-08-28 Bausch & Lomb Incorporated · 0 citations
  • VAI 2018-07-13 Bausch & Lomb, Incorporated · 2 citations
  • VAI 2018-07-13 Bausch & Lomb, Incorporated · 2 citations
  • NAI 2018-02-23 Bausch & Lomb Incorporated · 0 citations
  • NAI 2018-02-23 Bausch & Lomb Incorporated · 0 citations
  • VAI 2017-11-03 Bausch & Lomb Surgical, Inc. · 4 citations
  • NAI 2017-07-28 Total Titanium Inc · 0 citations
  • VAI 2017-04-05 Bausch & Lomb Surgical, Inc. · 4 citations
  • VAI 2017-02-15 Bausch & Lomb Incorporated · 1 citations
  • VAI 2017-02-15 Bausch & Lomb Incorporated · 1 citations
  • VAI 2016-10-05 Bausch & Lomb Incorporated · 5 citations
  • VAI 2016-10-05 Bausch & Lomb Incorporated · 5 citations
  • NAI 2016-06-10 Bausch & Lomb Inc · 0 citations