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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 81757

1 recalled-product record grouped only because every row carries this exact official event ID.

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Event summary

Timeline bucket
November 30, 2018
Product types
Device
Classifications
Class II
Statuses
Terminated
Recalling firm wording
Beaver Visitec

Dossier provenance

Source snapshots represented here

  • 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.

How coverage and grouping work

Complete imported group

Every recalled product in this event

1 official enforcement rows

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 1

BVI Visitec Soft Tip Cannula, 0.8MM .50 x 33mm (25G x 1.3 in). The BVI Soft Tip Cannula is intended to irrigate and/or aspirate ophthalmic solutions and liquids in or out of the eye, and remove materials where appropriate (e.g. retinal, subretinal procedures).

Z-1066-2019
Recall number
Z-1066-2019
Initiated
November 30, 2018
Classification
Class II
Status
Terminated
Recalling firm
Beaver Visitec
Quantity
3430 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Certain lots are missing a protective sheath component over the silicone tip, which may result in the silicone tip breaking or detaching at the metal tube component. If the tip becomes detached during a procedure while in the eye, the fragment will need to be retrieved to mitigate the possibility of injury.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Certain lots are missing a protective sheath component over the silicone tip, which may result in the silicone tip breaking or detaching at the metal tube component. If the tip becomes detached during a procedure while in the eye, the fragment will need to be retrieved to mitigate the possibility of injury.

Code information

Lots 60047S4, 60060S9, 600623S

Distribution pattern

Worldwide distribution: US (nationwide) to states of: AR, AZ, CA, CO, FL, GA, LA, MD, MO, NC, NE, NJ, NY, OH, OK, TX, UT, VA, WA; and countries of: Mexico and Peru.