MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional report with the FDA on 2016-12-16 for LENSTAR LS900 UNKNOWN manufactured by Haag-streit Ag.
[62603294]
A new lenstar ls900 s/n: (b)(4) and computer was installed by clinical application specialists from haag-streit usa. Haag-streit usa is currently awaiting for files to send to haag-streit (b)(4) for further evaluation.
Patient Sequence No: 1, Text Type: N, H10
[62603295]
The storage of the patient data was stored under the wrong patient. A patient was scanned with the lenstar ls900, s/n: (b)(4) around 4:15 pm on (b)(6) 2016 and the second patient was scanned around 4:23 pm on this same day. The biometry readings for the first patient were stored in eye suite under both patient names. The clinical application specialist verified with the iol printouts that the calculations were exactly the same, but the patient demographics at the top were different. This caused the iol calculations for the second patient to be inaccurate and they had the incorrect lenses installed during their surgery causing the need for a second surgery in order to correct.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1000176188-2016-00002 |
| MDR Report Key | 6181227 |
| Report Source | HEALTH PROFESSIONAL |
| Date Received | 2016-12-16 |
| Date of Report | 2016-12-16 |
| Date of Event | 2016-11-16 |
| Date Facility Aware | 2016-11-16 |
| Report Date | 2016-12-14 |
| Date Reported to Mfgr | 2016-12-14 |
| Device Manufacturer Date | 2012-08-16 |
| Date Added to Maude | 2016-12-16 |
| 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. BEAT HUGI |
| Manufacturer Street | GARTENSTADTSTRASSE 10 |
| Manufacturer City | KOENIZ, CH-3098 |
| Manufacturer Country | SZ |
| Manufacturer Postal | CH-3098 |
| Manufacturer Phone | 4131978011 |
| Manufacturer G1 | HAAG-STREIT AG |
| Manufacturer Street | GARTENSTADTSTRASSE 10 |
| Manufacturer City | KOENIZ, CH-3098 |
| Manufacturer Country | SZ |
| Manufacturer Postal Code | CH-3098 |
| Single Use | 3 |
| Remedial Action | OT |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | LENSTAR LS900 |
| Generic Name | LENSTAR, MODEL LS900 |
| Product Code | HJO |
| Date Received | 2016-12-16 |
| Model Number | LS900 |
| Catalog Number | UNKNOWN |
| Lot Number | UNKNOWN |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | 4 YR |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | HAAG-STREIT AG |
| Manufacturer Address | GARTENSTADTSTRASSE 10 KOENIZ, CH-3098 SZ CH-3098 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2016-12-16 |