Exact FDA event identifier

Event 69743

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

Open FDA event record

Event summary

Timeline bucket: November 11, 2014
Product types: Device
Classifications: Class II
Statuses: Terminated
Recalling firm wording: Alcon Research, Ltd.

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

Alcon Single-Use Curved Jewelers/Iris Bipolar Forceps REF 8065129101 Sterile RX only; Alcon Single-Use Straight/Iris Bipolar Forceps REF 8065129501 Sterile RX only. Usage: Electrosurgical instrument for ophthalmic surgery.

Z-0527-2015

Recall number: Z-0527-2015
Initiated: November 11, 2014
Classification: Class II
Status: Terminated
Recalling firm: Alcon Research, Ltd.
Quantity: 2321

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0

The product is sold and labeled as EO sterilized, however the units were not sterilized prior to shipment to customers.

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

The product is sold and labeled as EO sterilized, however the units were not sterilized prior to shipment to customers.

Code information

Lot numbers 061814-95 and 080614-91

Distribution pattern

Worldwide distribution: US (nationwide) and countries of: Indonesia, South Africa, Switzerland, Brazil, Kazakhstan, and Pakistan.