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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: AMO MANUFACTURING USA LLC INTRALASE FS LASER

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AMO MANUFACTURING USA LLC INTRALASE FS LASER Back to Search Results
Model Number R20004
Device Problem Normal
Event Date 11/18/2009
Event Type  Injury  
Manufacturer Narrative

In 2009, a field service engineer performed a preventative maintenance. The laser system met specifications and performed as intended. A clinical development specialist (cds) visited the site in order to obtain patient details and assess the laser settings. The cds made adjustments to the energy parameters, since then she reported she was unable to find any obl or difficulty with the lifts. Although a single root cause was not identified, the cds and the surgeon believe that the probable root cause for the dlk may have been attributed to the obl and the fact that the surgeon massaged the cornea, in order to complete the excimer treatment. Opaque bubble layer (obl), difficult lifts.

 
Event Description

The intralase fs laser was used to create bilateral corneal flap(s) for lasik surgery in 2009. During the surgery, the patient presented with opaque bubble layer (obl). The surgeon reported that because of the obl it was difficult to separate the flap. In order to complete the excimer treatment, the surgeon massaged the cornea very intensive in order to get rid of the obl. Two (2) days post-operatively, the patient presented with diffuse lamellar keratitis (dlk) on both (ou) eyes. A flap lift and rinse was performed ou and the patient was treated with topical steroids. A bandage contact lens (blc) was placed on the right (od) eye after surgery for one day. The patient's preoperative best corrected visual acuity (bcva) was 1. 0 od and 1. 25 for the left (os) eye. Patient's postoperative bcva is. 7 od and. 8 os. As of the following month, the patient's dlk had not resolved, the patient was still not satisfied.

 
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Brand NameINTRALASE FS LASER
Manufacturer (Section D)
AMO MANUFACTURING USA LLC
irvine CA 92618
Manufacturer (Section G)
AMO MANUFACTURING USA LLC
9701 jeronimo road
irvine CA 92618
Manufacturer Contact
angela pineda
1700 e. st. andrew place
sanata ana , CA 92705
7142478805
MDR Report Key1569406
Report Number3006695864-2009-00117
Device Sequence Number1
Product CodeHNO
Report Source Manufacturer
Source Type Foreign,Health Professional,User facility
Reporter Occupation Physician
Type of Report Initial
Report Date 11/30/2009
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received12/30/2009
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator Health Professional
Device MODEL NumberR20004
Device Catalogue NumberR20004
Was Device Available For Evaluation? Yes
Is The Reporter A Health Professional? Yes
Date Manufacturer Received11/30/2009
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured12/01/2005
Is The Device Single Use? No
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse

Patient TREATMENT DATA
Date Received: 12/30/2009 Patient Sequence Number: 1
Treatment
B&L EXCIMER LASER
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