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

Catalog Number 960569MA6001

Device Problems Component Missing (2306); Packaging Problem (3007)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 02/25/2015

Event Type  malfunction  

Event Description

A surgeon reported that the cannula locking ring was missing when the product package was opened.The device was used without the locking ring during surgery with no impact to the patient.Additional information has been requested.

Manufacturer Narrative

One carton with a used syringe was received and evaluated by manufacturing.The locking collar for the syringe cannula was missing.Possibly the blister with missing locking collar was not detected during the 100% visual control after the blistering process.The concerned operators will be retrained.No remarks were noted in the batch record for product blistering and a 100% inspection of the blisters has been performed.Blisters with missing components were removed.No similar complaints have been received for this lot.Root cause is attributed to internal packaging whereby the missing component was not detected during the 100% visual inspection after blistering.Since the potential impact on the market is low, no actions on the market are needed.(b)(4).

• Brand Name: PROVISC 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-28 70; BE B-2870
• Manufacturer Contact: janet moran ; 6201 south freeway; mail stop r3-48; fort worth, TX 76134 ; 8176152742
• MDR Report Key: 4624167
• MDR Text Key: 5759989
• Report Number: 3002037047-2015-00502
• Device Sequence Number: 1
• Product Code: LZP
• Combination Product (y/n): N
• Reporter Country Code: HU
• PMA/PMN Number: P890047
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional
• Reporter Occupation: Health Professional
• Remedial Action: Other
• Type of Report: Initial
• Report Date: 03/23/2015

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
• Device Operator: Health Professional
• Device Expiration Date: 03/31/2017
• Device Catalogue Number: 960569MA6001
• Device Lot Number: 14D29J
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/06/2015
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/25/2015
• Initial Date FDA Received: 03/23/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/29/2014
• 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
• Patient Outcome(s): Other