CARRIAZO-BARRAQUER (CB) 19315 *

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 00 report with the FDA on 2003-10-22 for CARRIAZO-BARRAQUER (CB) 19315 * manufactured by Moria S.a..

Event Text Entries

[21583926] The pt, was scheduled to undergo lasik surgery. According to the medical records prepared by the treating physician, bilateral lasik was scheduled. The physician performed the lasik on the right eye first. The physician cut a flap that was thinner than normal and may have had a tear in it. However, the physician failed to notice that the flap was thin and in violation of the standard of care, performed the laser ablation. After they performed the laser ablation, and laid the flap back down over the eye, the physician noticed that the flap was thin and had a tear in it. The physician claims that she then switched blades for the left eye and performed the microkertome cut in the cornea and the laser ablation without inicdent. Post-operatively, the physician applied a bandage contact lens right eye. At the first post-op exam, the tear in the flap of the right was almost not visible and appeared to be healing quite well, according the the physician's notes. The pt complained of double vision. In addition, left cornea began to develop striae, or wrinkles. The vision in the left eye began to deteriorate as well. The physcian referred pt to another dr for a second opinion and to recommend a course of treatment. The second surgeon first began treating the left eye be lifting the flap and stretching it to remove the striae. The patient's vision in the left eye is now 20/20. The second doctor then scheduled a lasik enhancement procedure for the right eye. The enhancement surgery took place about nine months after the pt's initial surgery. At the time of the enhancement in the right eye, the pt's vision in that eye was 20/50. The second surgeon cut another flap with a microkeratome in preparation for the laser ablation. When the second surgeon pulled the flap back to perform the ablation, he noticed that there was a thin strip of tissue that was completely unattached. The tissue was removed and the second surgeon performed the laser ablation. The second surgeon then returned the unattached tissue to what he felt was the appropriate place in the cornea. The independent medical exam conducted in 2003 concluded that the pt's best corrected visual acuity was 20/50 in right eye and 20/20 in left eye. The right eye had corneal scars consistent with two lasik procedures, as well as a striae line and epithelial irregularity. The independnet medical exam also concluded that pt has irregular astigmatism that could be causing decreased vision and double vision. Co has not reported this matter until now due to insufficient information about the pt's condition since the iniitial surgery and the enhancement and uncertainty about the facts of the incident. Co learned generally of the pt's medical complaint through lawsuit against the company in 2001, but co was only able to investigate the pt's condition through the discovery process and the independent medical examination. In lawsuit, the pt alleged that the irregular flap in right eye was attributable to a defective co blade. In support of this allegation, the pt referenced a product alert issued in 2000 to remind surgeons to inspect blades carefully before cutting the cornea with the microkeratome.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number2529598-2003-00002
MDR Report Key492247
Report Source00
Date Received2003-10-22
Date of Event2000-12-28
Date Added to Maude2003-10-31
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location0
Manufacturer ContactCHARLES MASTELLONE, CHIEF OPERATI
Manufacturer Street1050 CROSS KEYS DRIVE
Manufacturer CityDOYELSTOWN PA 18801
Manufacturer CountryUS
Manufacturer Postal18801
Manufacturer Phone2152307662
Manufacturer G1*
Manufacturer Street*
Manufacturer City*
Manufacturer Country*
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameCARRIAZO-BARRAQUER (CB)
Generic NameMICROKERATOME BLADE
Product CodeHMY
Date Received2003-10-22
Model Number19315
Catalog Number*
Lot NumberUNK
ID Number*
Device AvailabilityN
Device Eval'ed by MfgrN
Implant FlagN
Date RemovedA
Device Sequence No1
Device Event Key480946
ManufacturerMORIA S.A.
Manufacturer AddressC.E. #45 EVOLIC 1 ANTONY CEDEX FR 92182
Baseline Brand NameCARRIAZO-BARRAQUER (CB) MICROKERATOME
Baseline Generic NameMICROKERATOME
Baseline Model No19315
Baseline Catalog NoNA
Baseline IDNA
Baseline Device FamilyMICROKERATOME
Baseline Shelf Life [Months]NA
Baseline PMA FlagN
Baseline 510K PMNY
Premarket NotificationK981741
Baseline PreamendmentN
Baseline TransitionalN
510k ExemptN


Patients

Patient NumberTreatmentOutcomeDate
101. Other 2003-10-22

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