MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,03 report with the FDA on 2014-02-18 for NON-ABSORBABLE SURGICAL SUTURES UNK manufactured by Alcon Precision Device - Sinking Spring.
[19973155]
A literature article reported that following intraocular lens (iol) ciliary sulcus suture suspension procedure three patients had transient ocular hypertension. The event improved after intravenous injection of 20% mannitol and other treatment for 1 ~ 2 days.
Patient Sequence No: 1, Text Type: D, B5
[20302039]
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. Tan yunli and wang yanchun. Clinical observation of common posterior chamber intraocular lens suspension. Journal of bingtuan medicine, march 2013, vol 35, no. 1. (b)(4).
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2523835-2014-00026 |
| MDR Report Key | 3659685 |
| Report Source | 01,03 |
| Date Received | 2014-02-18 |
| Date of Report | 2014-01-17 |
| Date Mfgr Received | 2014-01-17 |
| Date Added to Maude | 2014-03-06 |
| 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 | 0 |
| 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 | ALCON PRECISION DEVICE - SINKING SPRING |
| Manufacturer Street | 714 COLUMBIA AVE. |
| Manufacturer City | SINKING SPRING PA 19608 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 19608 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | NON-ABSORBABLE SURGICAL SUTURES |
| Generic Name | NON-ABSORBABLE SUTURE |
| Product Code | GAS |
| Date Received | 2014-02-18 |
| Model Number | UNK |
| Catalog Number | UNK |
| Lot Number | UNK |
| 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 | ALCON PRECISION DEVICE - SINKING SPRING |
| Manufacturer Address | 714 COLUMBIA AVE. SINKING SPRING PA 19608 US 19608 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2014-02-18 |