MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a user facility report with the FDA on 2017-02-10 for IOLMASTER 500 000000-1692-983 manufactured by Carl Zeiss Meditec Ag (jena).
[67207364]
Patient Sequence No: 1, Text Type: N, H10
[67207385]
The health care professional reported the following: the os post refractive outcome after a cataract surgery with an intraocular lens (iol) implantation differed +2. 25 diopters from the target refraction. The alcon acrysof (b)(4) lens was used. The healthcare professional informed that a re-op is planned where an additional piggyback lens will be implanted. The iolmaster was used for the original biometry measurements and iol calculations.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9615030-2017-00002 |
| MDR Report Key | 6324126 |
| Report Source | USER FACILITY |
| Date Received | 2017-02-10 |
| Date of Report | 2017-08-03 |
| Date of Event | 2017-01-05 |
| Date Mfgr Received | 2017-01-12 |
| Device Manufacturer Date | 2014-11-07 |
| Date Added to Maude | 2017-02-10 |
| 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 | MR. WILLIAM GUSTAFSON |
| Manufacturer Street | 5160 HACIENDA DRIVE |
| Manufacturer City | DUBLIN CA 94568 |
| Manufacturer Country | US |
| Manufacturer Postal | 94568 |
| Manufacturer Phone | 9255574689 |
| Manufacturer G1 | CARL ZEISS MEDITEC AG (JENA) |
| Manufacturer Street | CARL ZEISS PROMENADE 10 |
| Manufacturer City | JENA, THURINGIA 07745 |
| Manufacturer Country | GM |
| Manufacturer Postal Code | 07745 |
| Single Use | 3 |
| Remedial Action | RL |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | IOLMASTER 500 |
| Generic Name | BIOMICROSCOPE, SLIT-LAMP, AC-POWERED |
| Product Code | HJO |
| Date Received | 2017-02-10 |
| Model Number | NA |
| Catalog Number | 000000-1692-983 |
| Lot Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | CARL ZEISS MEDITEC AG (JENA) |
| Manufacturer Address | CARL ZEISS PROMENADE 10 JENA, THURINGIA 07745 GM 07745 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2017-02-10 |