MAUDE Adverse Event Report: BAUSCH + LOMB OCUCOAT VISCOELASTIC; AID, SURGICAL, VISCOELASTIC

Model Number CC100SL

Device Problem Particulates (1451)

Patient Problems Uveitis (2122); No Information (3190); No Code Available (3191)

Event Date 08/12/2019

Event Type  Injury  

Manufacturer Narrative

Investigation of this event is in progress.A follow-up report will be submitted upon completion of the investigation.

Event Description

It was reported that 2 years ago, when a patient had post-operative uveitis a strand was found in the viscoelastic.The strand had to be removed from patients eye at the community hospital.Additional information has been requested.

Manufacturer Narrative

Investigation of this event is in progress.A follow-up report will be submitted upon completion of the investigation.

Event Description

It was reported that a cataract surgery was performed on the patient¿s right eye approximately one (1) year prior to the date of this report.On the same day the patient attended a different hospital for anterior chamber ac washout of a fibre residual from the cataract surgery.The intraocular lens (iol) was in the bag, but intraocular foreign body was noticed.The fibre was 5-8mm long and was noted to be a non-biological fibre on histology.A follow up examination was conducted on an unspecified date within four (4) weeks of the washout procedure.The patient has been seen in the ophthalmology department due to persistent uveitis.Additional information has been requested but not received.

Manufacturer Narrative

Though requested, no additional information has been received from the reporter.A device history record review was not performed as the lot number is unknown.The product was not returned, therefore no product evaluation was performed.There have been no additional uveitis events reported for this product for the last two years.A review of the nonconformance database did not identify any non-conformities that may be related to the reported event.The trend analysis, risk analysis and directions for use review are considered acceptable, with the product performing within anticipated rates.Based on the information provided the root cause for this event is undetermined.No corrective action is necessary at this time.

• Brand Name: OCUCOAT VISCOELASTIC
• Type of Device: AID, SURGICAL, VISCOELASTIC
• Manufacturer (Section D): BAUSCH + LOMB; 1400 n. goodman; rochester NY 14609
• MDR Report Key: 10488552
• MDR Text Key: 205513535
• Report Number: 0001313525-2020-00120
• Device Sequence Number: 1
• Product Code: LZP
• Combination Product (y/n): Y
• PMA/PMN Number: P860047
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial,Followup,Followup
• Report Date: 01/01/2005,08/07/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/03/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: CC100SL
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 01/01/2005
• Date Report to Manufacturer: 01/10/2005
• Date Manufacturer Received: 08/27/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention