MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 2015-06-18 for WAVESCAN WS1 0070-0150 manufactured by Abbott Medical Optics.
[5868345]
Account reported that patient had a decentered ablation with interrupted procedure in right eye and that as a result the patient experienced loss of best corrected visual acuity equal to 2 lines in his right eye. Patient history: pre-op manifest refraction on (b)(6) 2015: right eye +4. 50 -0. 50 x 040 bcva 20/20, left eye +3. 25 -0. 75 x 146 bcva 20/15. Patient ilasik treatment was (b)(6) 2015. Desired correction: right eye: +4. 72 -0. 64 x 034 with -0. 20 physician adjustment, left eye: +3. 46 -0. 63 x 146 with -0. 20 physician adjustment. Post op visit for (b)(6) 2015 bcva: right eye 20/30. Last post office visit was on (b)(6) 2015 and uncorrected visual acuity was: right eye 20/30, left eye 20/25, with no refraction in both eyes. Surgeon commented that he has observed the wavescan refraction has been 0. 50 diopter less than manifest refraction. Surgeon requested to have field service check out both systems, the wavescan and star excimer s4ir. This is 2 of 2 reports.
Patient Sequence No: 1, Text Type: D, B5
[13494710]
Application support manager (asm) discussed with surgeon that wavescan refraction sphere will be 0. 50 diopter less when compared to manifest refraction sphere due to monochromatic aberrations unless patient is accommodating. Plastics dated (b)(6) 2015 were checked and found with no artifacts. Customer did not have plastic for (b)(6) 2014. Wavescan daily calibration performed by the asm was found within specifications and a system checked by field service engineer (fse) found system within specifications. All pertinent information available to abbott medical optics has been submitted. Placeholder.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3006695864-2015-00301 |
| MDR Report Key | 4854830 |
| Report Source | 05,06 |
| Date Received | 2015-06-18 |
| Date of Report | 2015-05-22 |
| Date of Event | 2015-05-22 |
| Date Mfgr Received | 2015-05-22 |
| Date Added to Maude | 2015-06-18 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Contact | MRS. VALERIE SEDZICKI |
| Manufacturer Street | 1700 EAST ST. ANDREW PLACE |
| Manufacturer City | SANTA ANA CA 92705 |
| Manufacturer Country | US |
| Manufacturer Postal | 92705 |
| Manufacturer Phone | 7142478567 |
| Manufacturer G1 | ABBOTT MEDICAL OPTICS INC. |
| Manufacturer Street | 510 COTTONWOOD DRIVE |
| Manufacturer City | MILPITAS CA 95035 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 95035 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | WAVESCAN WS1 |
| Generic Name | REFRACTIVE MEASUREMENT |
| Product Code | HKO |
| Date Received | 2015-06-18 |
| Model Number | 0070-0150 |
| Operator | PHYSICIAN |
| Device Availability | Y |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ABBOTT MEDICAL OPTICS |
| Manufacturer Address | SANTA ANA CA US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2015-06-18 |