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Comfortear Lacrisolve 180 Absorbable Punctum Plug

Model 42702-176-04 · RIVERPOINT MEDICAL, LLC · DI 00810020082890

LZU — Plug, Punctum

UDILibrary device dossier · generated 2026-09-11 · 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.

01112023-07: 0 reports for this device; peer average 1/device2023-09: 0 reports for this device; peer average 1/device0709
Monthly adverse-event reports for this device versus the product-code average.
MonthThis device (reports)Product-code average (reports per device)
2023-0701
2023-0901
This device (reports/month)Average device in LZU (reports/device/month)

Regulatory clearances

  • None linked in the loaded window.

Manufacturer compliance record — RIVERPOINT MEDICAL, LLC

  • Warning Letter 2013-05-01 Riverpoint Medical, LLC
  • Warning Letter 2013-05-01 Riverpoint Medical, LLC
  • NAI 2016-03-16 Riverpoint Medical, LLC · 0 citations
  • NAI 2016-03-16 Riverpoint Medical, LLC · 0 citations
  • VAI 2013-12-02 Riverpoint Medical, LLC · 1 citations
  • VAI 2013-12-02 Riverpoint Medical, LLC · 1 citations
  • OAI 2013-02-04 Riverpoint Medical, LLC · 8 citations
  • OAI 2013-02-04 Riverpoint Medical, LLC · 8 citations
  • NAI 2011-08-04 Riverpoint Medical, LLC · 0 citations
  • NAI 2011-08-04 Riverpoint Medical, LLC · 0 citations