MAUDE Adverse Event Report: ALCON - COUVREUR N.V./ALCON - BELGIUM DISCOVISC OPHTHALMIC VISCOSURGICAL DEVICE; AID, SURGICAL, VISCOELASTIC

Catalog Number ASKU

Device Problem Product Quality Problem (1506)

Patient Problems Macular Edema (1822); Vitreous Loss (2142)

Event Date 03/31/2016

Event Type  Injury  

Manufacturer Narrative

No sample or lot number information has been received by manufacturing for evaluation.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.Additional information has been requested.(b)(4).

Event Description

A healthcare professional reported a surgeon's dissatisfaction with a viscoelastic product used during surgery in which the patient experienced a loss of vitreous.Procedure details, patient treatment and current status information is unknown.Additional information has been requested.Additional information received confirmed that the patient had an intraocular lens removed and is presently being treated for cystoid macular edema.

• Brand Name: DISCOVISC OPHTHALMIC VISCOSURGICAL DEVICE
• Type of Device: AID, SURGICAL, VISCOELASTIC
• Manufacturer (Section D): ALCON - COUVREUR N.V./ALCON - BELGIUM; rijksweg 14; puurs B-287 0; BE B-2870
• Manufacturer (Section G): ALCON - COUVREUR N.V./ALCON - BELGIUM; rijksweg 14; puurs B-287 0; BE B-2870
• Manufacturer Contact: eddie darton, md, jd ; 6201 south freeway; mail stop ab2-6; fort worth, TX 76134 ; 8175686660
• MDR Report Key: 5679218
• MDR Text Key: 45911150
• Report Number: 3002037047-2016-00098
• Device Sequence Number: 1
• Product Code: LZP
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P840064
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Health Professional
• Remedial Action: Other
• Type of Report: Initial
• Report Date: 05/25/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/25/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: ASKU
• Device Lot Number: ASKU
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/06/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: BSS
• Patient Outcome(s): Other
• Patient Age: 66 YR
• Patient Weight: 136