Food, drugs, devices › Lumenis, Inc.
Device recall: Array LaserLink, Manufactured by Lumenis, The Array" LaserLink" is a laser system accessory intended for use in the trea
FDA enforcement event 69139 is a device recall by Lumenis, Inc. of Salt Lake City, UT, initiated 15 Aug 2014 and classified Class II, with 1 product record.
FDA defines Class II as a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote. 91% of the 1,176 device enforcement events initiated in 2014 carry the same class.
Status: Terminated, terminated 21 Oct 2014. Initiation: voluntary: firm initiated. Lumenis, Inc. has 3 enforcement events on this register, with a median of 1 product record per event.
Recall classification reflects the relative degree of health hazard. Text in quotation marks is FDA's. openFDA export dated 28 Sep 2026.
Recalling firm
Lumenis, Inc., Salt Lake City, UT.
Reason for recall
"Lumenis initiated a field-correction for the Array Laser Link", GA-0006700 (SN XXYYZZ) because the system may project an erroneous pattern display on the retina, which is different than the desired pattern."
Distribution
"Worldwide Distribution - USA (nationwide) and Internationally to JAPAN, CHINA, and CANADA."
Product records
| Recall number | Product | Quantity | Class | Status | Report date |
|---|---|---|---|---|---|
| Z-2733-2014 | Array LaserLink, Manufactured by Lumenis, The Array" LaserLink" is a laser system accessory intended for use in the treatment of ocular pathology. " For the Posterior Segment, the Array" LaserLink" is indicated for use in Retinal Photocoagulation and Panretinal Photocoagulation of Vascular and Structural… | 16 | Class II | Terminated | 8 Oct 2014 |
Context
Other enforcement events for Lumenis, Inc.
| Initiated | Product (first record) | Type | Class | Records |
|---|---|---|---|---|
| 14 Oct 2021 | IPL Coupling Gel, I L (AX1009013), 12 pack of 0.25 L (AX1009018), 6 pack of 1 L (AX1009019 or AX1009063); and IPL Coupli | Device | Class I | 1 |
| 19 Aug 2013 | Vision One Laser System Model GA-0025020, Serial No: 10050, 10051, 10053. Intended for use in the treatment of ocular pa | Device | Class II | 1 |
All 3 events for Lumenis, Inc.
Questions and answers
Why was this device recalled?
FDA's record gives the reason for recall as: "Lumenis initiated a field-correction for the Array Laser Link", GA-0006700 (SN XXYYZZ) because the system may project an erroneous pattern display on the retina, which is different than the desired pattern."
What does Class II mean?
FDA classifies recalls by relative degree of health hazard. Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote.
Where was the product distributed?
FDA's distribution pattern field reads: "Worldwide Distribution - USA (nationwide) and Internationally to JAPAN, CHINA, and CANADA."
Is the recall still ongoing?
FDA lists the status as Terminated; the termination date is 21 Oct 2014. "Terminated" means FDA has determined that all reasonable efforts to remove or correct the product have been made.
Where does this data come from?
openFDA enforcement reports (food, drug and device), CC0, export dated 28 Sep 2026. Text in quotation marks is FDA's. The FDA enforcement report linked above is authoritative.
Provenance
Source: openFDA device enforcement reports (CC0), export dated 28 Sep 2026; records grouped by FDA event number. The class shown for the event is the most severe class among its records. Errors in processing are corrected at the next build; see corrections.