MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2014-07-31 for REFERENCE UNIT X-RUS 8065998240 manufactured by Wavelight Gmbh Agps.
[19603187]
A technician reported that following an intraocular lens (iol) implant procedure, a patient experienced an unexpected refractive outcome in the left eye. The lens was exchanged six weeks later for the same model lens, 1. 5 diopters difference in power. In a follow up, the surgeon reported that the system took inaccurate corneal measurements, which caused the incorrect iol power to be selected initially. The surgeon targeted for an outcome of -2. 00 for monovision, but the patient ended up with -3. 25. The event resolve with the iol exchange. No further information is expected.
Patient Sequence No: 1, Text Type: D, B5
[19882208]
Investigation, including root cause analysis, is in progress. A supplemental mdr will be filed as necessary in accordance with 21 cfr 803. 56 when additional reportable information becomes available. (b)(4).
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3010300699-2014-00006 |
| MDR Report Key | 4620851 |
| Report Source | 05 |
| Date Received | 2014-07-31 |
| Date of Report | 2014-07-03 |
| Date of Event | 2014-05-12 |
| Date Mfgr Received | 2014-07-03 |
| Date Added to Maude | 2015-03-23 |
| 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 | JANET MORAN |
| Manufacturer Street | 6201 SOUTH FREEWAY, R3-48 |
| Manufacturer City | FORT WORTH TX 76134 |
| Manufacturer Country | US |
| Manufacturer Postal | 76134 |
| Manufacturer Phone | 8176152742 |
| Manufacturer G1 | WAVELIGHT GMBH (AGPS) |
| Manufacturer Street | AM WOLFSMANTEL 5 |
| Manufacturer City | ERLANGEN 91058 |
| Manufacturer Country | GM |
| Manufacturer Postal Code | 91058 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Removal Correction Number | NA |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | REFERENCE UNIT |
| Generic Name | KERATOMETER, PUPILLOMETER |
| Product Code | HJB |
| Date Received | 2014-07-31 |
| Model Number | X-RUS |
| Catalog Number | 8065998240 |
| Lot Number | NA |
| ID Number | UNK |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | WAVELIGHT GMBH AGPS |
| Manufacturer Address | AM WOLFSMANTEL 5 ERLANGEN 91058 GM 91058 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2014-07-31 |