Skip to content
Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 73386

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

Open FDA event record

Event summary

Timeline bucket
February 22, 2016
Product types
Device
Classifications
Class II
Statuses
Terminated
Recalling firm wording
Innovative Ophthalmic Products, Inc

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

Molteno3 Glaucoma Implants G-Series: GS-Single Plate 175mm2 (IOP reorder#: M3-175) GL-Single Plate 230mm2 (IOP reorder#: M3-230)

Z-1252-2016
Recall number
Z-1252-2016
Initiated
February 22, 2016
Classification
Class II
Status
Terminated
Quantity
278 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Innovative Ophthalmic Products (IOP) is recalling the Molteno 3 G-Series Glaucoma Implant the package insert/Instructions for Use (IFU) for the device has been updated to add a caution statement to minimize off-label use.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Labeling False and Misleading

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Innovative Ophthalmic Products (IOP) is recalling the Molteno 3 G-Series Glaucoma Implant the package insert/Instructions for Use (IFU) for the device has been updated to add a caution statement to minimize off-label use.

Code information

GS2014 GL2014 GL2015 GS2015

Distribution pattern

Nationwide Distribution

Field note

Send feedback

We'll only use this to respond to your feedback.