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AMO VISX STAR Excimer Laser System, manufactured by VISX… recallZ-1139-2008 · Visx Incorporated, A Subsidiary Of Amo Inc · initiated Dec 13, 2007

Terminated All recalls posted in June 2008

Is my device affected?

  1. Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
  2. If yours is listed, follow the instructions from Visx Incorporated, A Subsidiary Of Amo Inc or your healthcare provider. The company's action is summarized under what the company is doing.
  3. Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.

Where to find your model and lot numbers · What recall classes and statuses mean

Why it was recalled

Firm received two complaints (including one injury complaint) associated with the movement of the VISX chair while in the patient loading ("fully swung out" unlocked) position under an IntraLase FS laser.

FDA root cause category: Component design/selection

What the company is doing

On December 13, 2007, firm issued an Urgent Safety Notice to all VISX and IntraLase laser owners related to recall. The Safety Notice contains information related to the measures that can be taken to prevent unintentional movement of any chair during other procedures. AMO is initiating a field corrective action, whereby Field Service Engineers will visit each practice that owns both systems to disable the VISX chair back switch. For additional information, please contact AMO at (714) 247-8656.

Recall details

Recall number
Z-1139-2008
Recall class
Not yet classified by the FDA
Status
Terminated
Initiated by the company
Dec 13, 2007
Posted by the FDA
Jun 5, 2008
Recalling firm
Visx Incorporated, A Subsidiary Of Amo Inc
Quantity
1,853 units
Product code
LZS
FDA submissions
P930016
Distribution
Worldwide Distribution - USA, including the states of: AK AL AR AZ CA CO CT DC DE FL GA HI IA ID IL IN KS KY LA MA MD MI MN MO MS MT NC ND NE NH NJ NM NV NY OH OK OR PA PR RI SC SD TN TX UT VA VT WA WI WV and countries of: Argentina Australia Austria Bahrain Belgium Bolivia Brazil Bulgaria Canada Chile China Colombia Costa Rica Cyprus Czech Republic Djibouti Dominican Rep. Ecuador Egypt Finland France Germany Great Britain Greece Hong Kong India Indonesia Ireland Israel Italy Japan Jordan Kasachstan Kuwait Lebanon Malaysia Martinique Mexico Mongolia Netherlands New Zealand Norway Oman Pakistan Paraguay Philippines Poland Portugal Russian Fed. Saudi Arabia Singapore Slovakia South Africa South Korea Spain Sweden Switzerland Taiwan Thailand Trinidad,Tobago Turkey Unit.Arab Emir. Venezuela Vietnam

Product description

AMO VISX STAR Excimer Laser System, manufactured by VISX, Santa Clara, CA 95051

Code information (models, lots, serial numbers)

Show the full code information (1k characters)

VISX STAR Excimer Laser Sysem 0030-4864 Chair component of the System 0030-2381 Each chair also has a serial number, which is the same as the serial number assigned to the system it is part of. Serial Numbers:  2129 2146 2181 2197 3028 3030 3031 3036 3480 3624 5346 5635 3751 3863 5345 5088 3113 5065 3938 2158 2177 2204 2205 3254 3387 3397 3754 3937 5030 5122 3023 3194 3435 3456 3732 3830 5027 5283 5313 5334 5382 5456 5566 5606 5643 3037 3122 3130 3233 3246 3874 5006 5021 5032 5125 5224 5415 5671 3574 5306 5695 3816 2200 3029 3284 3293 3528 3536 3697 3712 3731 3802 3840 3927 5012 5014 5034 5064 5079 5151 5153 5154 5175 5231 5267 5287 5307 5317 5410 5559 5573 5656 5720 5779 3884 5649 3314 3974 5495 3241 and 5127

Other devices under the same FDA submission

1 device cleared under P930016 — the recall does not name any of them by identifier. One submission often covers many models, so they may or may not be affected.

Sources and updates

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