Severity
Moderate
ModerateClass IITerminated
FDA Devices recall · Reported September 21, 2016
LAUREATE World Phaco System
Steps 16-25 are missing from the LAUREATE Multipak FMS Directions for Use (DFU)
Compiled from official public sources by the editorial team.
Verify with FDA Devices →
Alcon Research, Ltd. recalled LAUREATE World Phaco System - a moderate-severity action.
LAUREATE World Phaco System was recalled by Alcon Research, Ltd. in September 21, 2016. Reason: Steps 16-25 are missing from the LAUREATE Multipak FMS Directions for Use (DFU). Check the official notice for the remedy. Verify recall #Z-2834-2016 with the FDA Devices before acting.
The recall
Alcon Research, Ltd. issued this moderate-severity FDA Devices recall-Steps 16-25 are missing from the LAUREATE Multipak FMS Directions for Use (DFU).
- Moderate
- severity level
- 9K units
- affected scope
- Class II
- classification
- September 21, 2016
- reported
Sourced from official FDA Devices enforcement records. Verify recall #Z-2834-2016 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
Recall Insight
This FDA Devices action (record #Z-2834-2016) was formally reported on September 21, 2016, with the manufacturer initiating the action on July 28, 2016. It is classified under Moderate severity (Class II), with a current status of Terminated. Alcon Research, Ltd. is listed as the recalling firm, operating out of Fort Worth, TX. Federal records list the affected scope as 8,646 UNITS.
The documented reason for this recall is: Steps 16-25 are missing from the LAUREATE Multipak FMS Directions for Use (DFU) Distribution data in the federal record shows the product reached: Burundi, China, Iran, South Korea, Taiwan, Thailand, USA. *** The recalled product is not sold in the USA or its territories. However, donated units are in use by a reduced number of USA clients for Medical Missions ou…. Distribution scope directly affects the consumer exposure window and determines whether a recall remains regional or escalates into a nationwide advisory.
Within the same product category the archive holds 6 closely related recalls, 3 from FDA Devices - clustering in a narrow category often points to a systemic quality-control or supplier issue rather than a one-off defect. Always verify the recall number against the official agency record before acting.
Medical Devices recalls over time
Where this recall sits in its category - 40,322 medical devices recalls on record
Of 101,704 recalls in the database, 24,878 are high severity, 72,426 moderate, and 4,400 low. This recall is classified moderate severity.
Counts reflect market size and reporting activity, not inherent danger, we do not rank products by risk from raw recall volume.
Affected scope
8,646 UNITS
Related Recalls
6
3 from same agency
Product description
LAUREATE World Phaco System
Reason for recall
Steps 16-25 are missing from the LAUREATE Multipak FMS Directions for Use (DFU)
Recall Profile
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Moderate (Class II) |
| Status | Terminated |
| Recall number | Z-2834-2016 |
| Date reported | September 21, 2016 |
| Date initiated | July 28, 2016 |
| Recalling firm | Alcon Research, Ltd. |
| Firm location | Fort Worth, TX |
| Affected scope | 8,646 UNITS |
| Distribution | Burundi, China, Iran, South Korea, Taiwan, Thailand, USA. *** The recalled product is not sold in the USA or its territories. However, donated units are in use by a reduced number of USA clients for Medical Missions outside the country. |
Profile values are sourced directly from the official FDA Devices enforcement record. Source: U.S. Food and Drug Administration.
What to do with this recall
Match your product against the recall record, then act on the agency remedy.
- Check the recall number (Z-2834-2016) and product description against the item you own. Search the archive
- Confirm the current status with FDA Devices before acting, recall details can be updated.
- Follow the documented remedy (refund, replacement, repair, or disposal) rather than general advice. What to do next
This page summarizes the official FDA Devices record for research and awareness; it is not legal, medical, or safety advice. Verify with the issuing agency before acting.
Frequently Asked Questions
What product was recalled? ▼
LAUREATE World Phaco System. Recalled by Alcon Research, Ltd.. Units affected: 8,646 UNITS.
Why was this product recalled? ▼
Steps 16-25 are missing from the LAUREATE Multipak FMS Directions for Use (DFU)
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on September 21, 2016. Severity: Moderate. Recall number: Z-2834-2016.
Where was the recalled product distributed? ▼
Distribution: Burundi, China, Iran, South Korea, Taiwan, Thailand, USA. *** The recalled product is not sold in the USA or its territories. However, donated units are in use by a reduced number of USA clients for Medical Missions outside the country..
How do I check if my product is affected by a recall? ▼
Check the product description and recall number (Z-2834-2016) against your product. Visit the official FDA Devices website for the most current information. You can also use our Recall Checker tool to search by product name or brand.
Should I stop using a recalled medication or medical device? ▼
Do not stop using a recalled medication or device without consulting your healthcare provider first, as abruptly discontinuing treatment could pose its own health risks. Your doctor can advise on alternatives or whether the recall applies to your specific product lot. Check the recall number and lot information against your product packaging.
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Every figure on PlainRecalls is rendered directly from official FDA, CPSC and NHTSA recall records, no number is typed in by an editor. This recall: FDA Devices, reported September 21, 2016. Severity classes follow each agency's own taxonomy (FDA Class I/II/III; CPSC and NHTSA by hazard type), and related-recall context is computed across the full archive. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error. Data current as of July 2026.