NON-ABSORBABLE SURGICAL SUTURES
Received Feb 18, 2014
Report 2523835-2014-00024 · MDR key 3659672
Device
Generic name
Non-absorbable Suture
Manufacturer
Alcon Precision Device - Sinking SpringModel number
UNKCatalog number
UNK
Lot number
UNK
Product problems
- Adverse Event Without Identified Device or Use Problem
Patient
Not reported
- Corneal Edema
- No Code Available
Narrative
Description of Event or Problem
A LITERATURE ARTICLE REPORTED THAT FOLLOWING INTRAOCULAR LENS (IOL) CILIARY SULCUS SUTURE SUSPENSION PROCEDURE ALL PATIENTS HAD VARYING DEGREES OF POSTOPERATIVE CORNEAL EDEMA AND SOME PATIENTS HAD ANTERIOR CHAMBER FIBRIN EXUDATION. IT WAS NOTED THAT ALL PATIENTS RECOVERED AFTER ANTI-INFLAMMATORY SYMPTOMATIC TREATMENT.
Additional Manufacturer Narrative
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, MAR. 2013, VOL 35, NO. 1. (B)(4).