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 2018-03-09 for IDESIGN AWS SYSTEM 0110-2261 manufactured by Johnson & Johnson Surgical Vision, Inc..
[102073116]
(b)(4). All pertinent information available to johnson & johnson surgical vision, inc. Has been submitted.
Patient Sequence No: 1, Text Type: N, H10
[102073117]
The clinic reported that a laser vision correction patient had surgery on (b)(6) 2017. At 3 day post op uncorrected visual acuity in right eye was 20/50 -1 with pinhole at 20/20-1 and left eye was 20/50-2 with pinhole at 20/30 +2. 5 day post op uncorrected visual acuity right 20/30 -2 and left 20/25 +2 6 day post op uncorrected visual acuity right 20/20 and left 20/25 +-1 refraction right. 75 x -0. 50 x005 20/20 -1 left plano -. 50 x 142 20/25 -1 2+ superficial punctate keratitis both eyes 11 day post op uncorrected visual acuity right 20/30 and left 20/30 +-1 refraction right 2. 25 x -0. 50 x 180 20/25-2 left 1. 75 -. 50 x 007 20/25 -2 inferior 1+ superficial punctate keratitis in both eyes quick taper on lotemax 4 times a day, for 3 days then discontinue and artificial tears every hour. 18 day post op uncorrected visual acuity right 20/30-1 and left 20/30 -1 with horizontal diplopia refraction right 3. 50 x -0. 50 x 150 20/20 -1 left 1. 75 -. 50 x 005 20/25 -2 23 day post op ((b)(6) 2017) uncorrected visual acuity right 20/40 +2 and left 20/30 -1 refraction right 3. 50 x -0. 50 x 150 20/20 -1 left 1. 75 -. 50 x 005 20/25 -2 started clapiks (contact lens-assisted, pharmacologically induced keratosteepening) on (b)(6) 2017 after wearing clapiks patient states he is only wearing it in right eye as left was too painful and stop wearing it on (b)(6) 2017. Refraction right plano x -0. 50 x 180 20/20 -1 left 1. 75 -. 50 x 017 20/20 stopped clapiks. On (b)(6) 2017 patient notes shadows mostly at near however, feels it is getting better. Uncorrected right 20/20-2 20/20 left refraction right. 50 x -0. 50 x 180 20/20 left. 50 -. 50 x 022 20/20 patient has no loss of best corrected visual acuity. This case is for the idesign system. A separate report is being submitted for the visx laser.
Patient Sequence No: 1, Text Type: D, B5
[110083659]
Initially reported device manufacturing date from 9/8/2017 to corrected device manufacturing date 5/23/2017. 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. All pertinent information available to johnson and johnson surgical vision has been submitted.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3006695864-2018-00486 |
| MDR Report Key | 7329213 |
| Report Source | HEALTH PROFESSIONAL,USER FACI |
| Date Received | 2018-03-09 |
| Date of Report | 2018-04-16 |
| Date of Event | 2017-10-20 |
| Date Mfgr Received | 2018-03-19 |
| Device Manufacturer Date | 2017-05-23 |
| Date Added to Maude | 2018-03-09 |
| 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 | JOHNSON & JOHNSON SURGICAL VISION, 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 | 2018-03-09 |
| Model Number | 0110-2261 |
| Catalog Number | 0110-2261 |
| 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 | JOHNSON & JOHNSON SURGICAL VISION, INC. |
| Manufacturer Address | SANTA ANA CA US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2018-03-09 |