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

Catalog Number 960545J--001/0

Device Problem Insufficient Information (3190)

Patient Problems Intraocular Pressure Increased (1937); Rupture (2208)

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 doctor reported that a viscoelastic product was used during surgery after which the patient's intraocular pressure (iop) spiked to 41 mmhg.The elevated iop was believed to have caused posterior capsule rupture which then had to be surgically treated by vitrectomy.Additional information has been requested.

Manufacturer Narrative

The manufacturer internal reference number is: (b)(4).

Event Description

Additional information has been received from the doctor who states that there is no causal relationship between viscoelastic product use and the patient's elevated intraocular pressure (iop).Additionally, it was confirmed that the reported posterior capsule rupture is attributed to a poke from the tip of an instrument that was being used during the surgery.There is now no complaint with the originally reported product.No further information is available or expected for this report.

• 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
• MDR Report Key: 7600551
• MDR Text Key: 111019111
• Report Number: 3002037047-2018-00011
• Device Sequence Number: 1
• Product Code: LZP
• Combination Product (y/n): N
• PMA/PMN Number: P840064
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date: 08/10/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/14/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 960545J--001/0
• Device Lot Number: ASKU
• Other Device ID Number: 4987483006438
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 08/06/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other