MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a foreign,health professional,u report with the FDA on 2018-02-07 for IDESIGN AWS SYSTEM 0110-0001 manufactured by Abbott Medical Optics.
[99302104]
(b)(4). Fse on site completed the following: viewed all technicians that utilized the idesign during the capture sequence. Completed idesign clinical optimization checklist. Asm discussed outcomes with the tlc account regional director, clinic director and the physician. It was found that physician planned all treatments and the nomogram used was gleaned from a different tlc site in (b)(6). Two other physicians mentioned that the physician reporting the issues comes in (to the center) and steps into the footpedal. All pertinent information available to abbott medical optics has been submitted.
Patient Sequence No: 1, Text Type: N, H10
[99302105]
The clinic reported that a laser vision correction patient had surgery on (b)(6) 2017 and presented on 1 month post-op with an astigmatism in both eyes. It was stated that the patient had a loss of best corrected visual acuity (bcva).? Bcva: right eye pre-op 20/20 -5. 00 x -. 50 x 49, left eye pre-op 20/20 -4. 75 x. 00 x 0. Bcva 1 month post-op: right eye post-op 20/30. 50 x -. 50 x 35, left eye post-op 20/30. 50 x -. 25 x 155. This report is for the idesign aberrometer. A separate report is being submitted for the excimer laser.
Patient Sequence No: 1, Text Type: D, B5
[111214987]
Correction: initially reported device manufacturing date from 11/1/2016 to corrected device manufacturing date august 2016. Device evaluation: a review of the records related to the device that included labeling, manuals, trending, and risk documentation was performed. The trend review shows that there is not significant change over historical complaint limits and no recognizable adverse trend. The risks and mitigations associated with the complaint issue are identified in existing risk documents and no new risks were identified as part of this investigation. There was no product deficiency identified. The review of the device history record (dhr) the refractive idesign showed that there were no issues or non-conformities. Manufacturing has been ruled out as a potential cause for the reported issue. No conclusive evidence identified for reported issue. All pertinent information available to johnson & johnson surgical vision, inc. Has been submitted.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3006695864-2018-00227 |
| MDR Report Key | 7249995 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL,U |
| Date Received | 2018-02-07 |
| Date of Report | 2018-03-09 |
| Date of Event | 2017-12-14 |
| Date Mfgr Received | 2018-02-12 |
| Device Manufacturer Date | 2016-11-01 |
| Date Added to Maude | 2018-02-07 |
| 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 | 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 | IDESIGN AWS SYSTEM |
| Generic Name | REFRACTIVE MEASUREMENT |
| Product Code | HKO |
| Date Received | 2018-02-07 |
| Model Number | 0110-0001 |
| ID Number | NI |
| Operator | PHYSICIAN |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| 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 | 2018-02-07 |