MAUDE Adverse Event Report: BAUSCH + LOMB BAUSCH + LOMB INJECTOR SYSTEM CARTRIDGE; FOLDERS AND INJECTORS, INTRAOCULAR LENS (IOL)

Model Number BLIS-X1

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Vitreous Loss (2142); Capsular Bag Tear (2639); Vitrectomy (2643); No Code Available (3191)

Event Date 10/08/2019

Event Type  Injury  

Manufacturer Narrative

Though requested, no additional information has been received.The product was not returned for evaluation; consequently, no product evaluation was performed.A device history review could not be performed as no lot number has been provided.Based upon the complaint trend review, the volume of complaints is within the acceptable control limits and no complaint trend is observed.The trend analysis, risk analysis and/or directions for use review were considered acceptable, with the product performing within anticipated rates.Proper loading of the intraocular lens (iol) in accordance with the directions for use is essential in facilitating the folding process of the iol.Incorrect loading can result in similar folding issues.In addition, the added viscoelastic (ovd) may also influence the folding of the iol.The iol may rub harder during advancing if too little viscoelastic is applied, or if zones of the loading chamber remain dry.Based on the current information, the root cause of the event could not be conclusively determined; however, user related factors, such as loading issues might have contributed to the event.No corrective action is necessary at this time.

Event Description

It was reported that during the insertion of an intraocular lens (iol) there was a lens folding issue with the leading haptic.The incision was enlarged to remove the lens intraoperatively, and sutures were required.Though requested, no additional information has been received.

Event Description

The capsular bag was damaged in the right eye, and there was a loss of vitreous.A vitrectomy was performed and the incision was enlarged to remove the intraocular lens (iol).Sutures were used.The iol damage was noticed intraoperatively.The plan of surgery was changed to 3 piece iol, and the second iol was implanted successfully.In the physician¿s opinion, the most likely cause of the iol damage was lens stuck in delivery device.Good patient prognosis.

Manufacturer Narrative

The conclusions from the original submission remain unchanged.

• Brand Name: BAUSCH + LOMB INJECTOR SYSTEM CARTRIDGE
• Type of Device: FOLDERS AND INJECTORS, INTRAOCULAR LENS (IOL)
• Manufacturer (Section D): BAUSCH + LOMB; 1400 n. goodman; rochester NY 14609
• MDR Report Key: 9707634
• MDR Text Key: 183908164
• Report Number: 0001313525-2020-00033
• Device Sequence Number: 1
• Product Code: MSS
• Combination Product (y/n): Y
• PMA/PMN Number: K131958
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,user facility
• Type of Report: Initial,Followup
• Report Date: 01/01/2005,10/23/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: BLIS-X1
• 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
• Initial Date Manufacturer Received: 01/16/2020
• Initial Date FDA Received: 02/13/2020
• Supplement Dates Manufacturer Received: 02/14/2020
• Supplement Dates FDA Received: 03/13/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: ENVISTA TORIC INTRAOCULAR LENS
• Patient Outcome(s): Required Intervention
• Patient Age: 91 YR