MAUDE Adverse Event Report: BAUSCH + LOMB BAUSCH + LOMB VIS100 INJECTOR SYSTEM; FOLDERS AND INJECTORS, INTRAOCULAR LENS (IOL)

Model Number VIS100

Device Problems Break (1069); Use of Device Problem (1670); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Eye Injury (1845); No Known Impact Or Consequence To Patient (2692)

Event Date 04/23/2019

Event Type  Injury  

Manufacturer Narrative

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

Event Description

It was reported that the lens was removed and replaced with different model lens same diopter intraoperatively due to a broken haptic.

Manufacturer Narrative

The product was not returned for evaluation; consequently, no product evaluation was performed.Trend analysis, risk analysis and/or directions for use review were considered acceptable, with the product performing within anticipated rates.The device history record (dhr) was reviewed and there were no discrepancies or unusual findings that relate to the reported issue.Based on the current information, the root cause of the event could not be conclusively determined.However, the most probable cause may be related to operational context, wherein if the intraocular lens (iol) is not loaded according to the directions for use (dfu), the iol haptics could be pinched during the closing process of the cartridge wings.As a consequence, the plunger will elongate the optic from the haptic.The increasing of the advancing force will be directed to the junction (haptic to optic) and may tear the haptic off.It is important to manage the haptics during the closing procedure.This can be ensured with a sterile loading forceps by pressing the optic down and align the haptics towards the optic.If additional information becomes available, an additional investigation will be conducted.No corrective action necessary at this time.

Event Description

It should be specified that sutures were required in order to complete the reported surgery.Additional information has been requested, but has not been received.

• Brand Name: BAUSCH + LOMB VIS100 INJECTOR SYSTEM
• Type of Device: FOLDERS AND INJECTORS, INTRAOCULAR LENS (IOL)
• Manufacturer (Section D): BAUSCH + LOMB; 1400 north goodman st; rochester NY 14609
• MDR Report Key: 8664841
• MDR Text Key: 146911133
• Report Number: 0001313525-2019-00092
• Device Sequence Number: 1
• Product Code: MSS
• Combination Product (y/n): Y
• PMA/PMN Number: K133146
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Type of Report: Initial,Followup
• Report Date: 01/01/2005,05/06/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/03/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 08/31/2020
• Device Model Number: VIS100
• Device Lot Number: 1880B3
• 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: 07/11/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: AKREOS ADVANCED OPTICS IOL
• Patient Outcome(s): Other