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 2016-12-17 for IOLMASTER 700 000000-1932-169 manufactured by Carl Zeiss Meditec Ag (jena).
[62671738]
This is case two of two reported from same customer site in (b)(6). The health care professional (hcp) reported that the post refractive outcome after a cataract surgery with intraocular lens (iol) implantation was different from the target refraction. The healthcare professional made a decision to exchange the iol. No further information regarding the patient and incident could be obtained. The hcp used the iolmaster 700 for the biometry measurements and iol calculations.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9615030-2016-00011 |
| MDR Report Key | 6184259 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL,U |
| Date Received | 2016-12-17 |
| Date of Report | 2016-11-18 |
| Date Mfgr Received | 2016-11-18 |
| Device Manufacturer Date | 2014-11-26 |
| Date Added to Maude | 2016-12-17 |
| 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 | IN |
| Previous Use Code | 3 |
| Removal Correction Number | NA |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | IOLMASTER 700 |
| Generic Name | BIOMICROSCOPE, SLIT-LAMP, AC-POWERED |
| Product Code | HJO |
| Date Received | 2016-12-17 |
| Model Number | NA |
| Catalog Number | 000000-1932-169 |
| 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 | 2016-12-17 |