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

Model Number BLIS-X1

Device Problem Contamination of Device Ingredient or Reagent (2901)

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

Event Date 04/29/2019

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 the lens was removed and replaced intra-operatively due to white matter on the lens.The incision was enlarged and the same model and diopter lens was implanted as a back-up.The patient has made a full recovery.

Manufacturer Narrative

The product was not returned for evaluation; consequently, no product evaluation was performed.The complaint could not be confirmed.There are several different causes that could potentially be attributed to this issue.One potential reason is that the appearance of the intraocular lens (iol) may be changed by improper manipulation with forceps.Another factor may be that some iol marks may be caused by improper additive transfer (sourced by the loading chamber).Such marks are 100% biocompatible and typically disappear after several days or weeks.A definitive root cause cannot be determined.A device history record (dhr) review could not be completed 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 directions for use review were considered acceptable, with the product performing within anticipated rates.No corrective action is necessary at this time.

• Brand Name: BAUSCH + LOMB INJECTOR SYSTEM CARTRIDGE
• Type of Device: FOLDERS AND INJECTORS, INTRAOCULAR LENS (IOL)
• Manufacturer (Section D): BAUSCH + LOMB; 1400 north goodman street; rochester NY 14609
• MDR Report Key: 8650623
• MDR Text Key: 146391159
• Report Number: 0001313525-2019-00089
• 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: 01/01/2005,04/29/2019

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
• 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: Not provided
• Initial Date FDA Received: 05/29/2019
• Supplement Dates Manufacturer Received: 07/12/2019
• Supplement Dates FDA Received: 08/09/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: ENVISTA LENS, AMVISC PLUS VISCOELASTIC; ENVISTA LENS, AMVISC PLUS VISCOELASTIC
• Patient Outcome(s): Other
• Patient Age: 64 YR