| Brand Name | GRIESHABER Advanced DSP Tip Scissors |
| Common Device Name | Scissors, Ophthalmic |
| Manufacturer (Section D) |
| Alcon Grieshaber AG |
| winkelriedstrasse 52 |
| schaffhausen 8203 |
| SZ 8203 |
|
| Manufacturer (Section G) |
| Alcon Grieshaber AG |
| winkelriedstrasse 52 |
|
| schaffhausen 8203 |
|
SZ
8203
|
|
| Manufacturer Contact |
|
jonathan
schlech
|
| 6201 south freeway |
| mail stop ab2-6 |
| fort worth, TX 76134
|
|
+1(800)757-9780
|
|
| MDR Report Key | 50372803 |
| Report Number | 3003398873-2026-00176 |
| Device Sequence Number | 15946238 |
| Product Code |
HNF
|
| UDI-Device Identifier | 07612717071070 |
| UDI-Public | (01)07612717071070(17)281031(11)251124(10)17TXD0 |
| Combination Product (Y/N) | N |
| Initial Reporter Country | US |
| PMA/510(K) Number | EXEMPT |
| Number of Events Summarized | 1 |
| Summary Report (Y/N) | N |
| Reporter Type |
Manufacturer
|
| Report Source |
Foreign |
| Initial Reporter Occupation |
Non-Healthcare Professional
|
| Type of Report
| Initial,Followup |
| Report Date (Section B) |
09/30/2026 |
| 1 Device was Involved in the Event |
|
| 1 Patient was Involved in the Event |
|
| Is this an Adverse Event Report? |
No
|
| Is this a Product Problem Report? |
Yes
|
| Operator of Device |
Health Professional
|
| Device Catalogue Number | 725.52P |
| Device Lot Number | 17TXD0 |
| Was Device Available for Evaluation? |
No
|
| Is the Reporter a Health Professional? |
No
|
| Initial Date Received by Manufacturer | Not provided |
| Supplement Date Received by Manufacturer | 09/17/2026
|
| Initial Report FDA Received Date | 08/21/2026 |
| Supplement Report FDA Received Date | 09/30/2026
|
| Date Device Manufactured | 11/24/2025 |
Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N) |
No
|
| Usage of Device |
Initial
|
| Patient Sequence Number | 1 |
| Patient Sex | Unknown |