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

Model Number BLIS-X1

Device Problem Use of Device Problem (1670)

Patient Problem No Code Available (3191)

Event Date 10/06/2020

Event Type  Injury  

Manufacturer Narrative

The device was not available for return.Investigation of this event is still in progress.A follow-up report will be submitted upon completion of investigation.

Event Description

Reportedly, lens was loaded into the wrong cartridge.Customer used a bausch and lomb blis injector system instead of a 3-piece loading system.Lens did not have a smooth entry and the haptic was broken.Incision had to be enlarged to remove the lens without needing sutures.Additional information has been requested and not received.

Manufacturer Narrative

Additional information: h10/11 additional information was received, indicating this event is not related to the reported device; and therefore, is no longer reportable.

• Brand Name: BAUSCH + LOMB INJECTOR SYSTEM CARTRIDGE
• Type of Device: FOLDERS AND INJECTORS, INTRAOCULAR LENS (IOL)
• Manufacturer (Section D): BAUSCH + LOMB; 1400 north goodman st.; rochester NY 14609
• MDR Report Key: 10879813
• MDR Text Key: 217930766
• Report Number: 0001313525-2020-00179
• 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: health professional,user faci
• Type of Report: Initial,Followup
• Report Date: 10/19/2020

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: 1928H6
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 11/20/2020
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 12/18/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: SOFPORT AO INTRAOCULAR LENS
• Patient Outcome(s): Required Intervention