MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional,user faci report with the FDA on 2015-10-29 for WAVESCAN FOURIER ALGORITHM 0070-1006 manufactured by Abbott Medical Optics.
[29870896]
(b)(4). The clinic is reporting this adverse event only and did not request or require field service or clinical support. All pertinent information available to abbott medical optics has been submitted.
Patient Sequence No: 1, Text Type: N, H10
[29870897]
The clinic reported that a laser vision correction patient had surgery and presented on (b)(6) 2015 with epithelial ingrowth in right eye post treatment. It was stated that the patient had no loss of best corrected visual acuity (bcva). The patient reported having discomfort and irritation. Secondary surgical intervention was required and surgeon performed a lift/clean on (b)(6) 2015. Patient reported symptoms are not interfering with daily activities. Bcva from (b)(6) 2015: right eye pre-op 20/20 -2. 50 x -2. 25 x 26; left eye pre-op 20/20 -3. 00 x -2. 25 x 165. Bcva from (b)(6) 2015: right eye post-op 20/15. 50 x -. 25 x 131; left eye post-op 20/20. 50 x -. 50 x 68.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3006695864-2015-00756 |
| MDR Report Key | 5188712 |
| Report Source | HEALTH PROFESSIONAL,USER FACI |
| Date Received | 2015-10-29 |
| Date of Report | 2015-10-29 |
| Date of Event | 2015-03-12 |
| Date Mfgr Received | 2015-10-01 |
| Device Manufacturer Date | 2004-09-19 |
| Date Added to Maude | 2015-10-29 |
| 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 | 3 |
| Event Location | 3 |
| 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 FOURIER ALGORITHM |
| Generic Name | REFRACTIVE MEASUREMENT |
| Product Code | HKO |
| Date Received | 2015-10-29 |
| Model Number | 0070-1006 |
| 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. Required No Informationntervention | 2015-10-29 |