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

Model Number BLIS-X1

Device Problems Adverse Event Without Identified Device or Use Problem (2993); Insufficient Information (3190)

Patient Problems Capsular Bag Tear (2639); Vitrectomy (2643)

Event Date 12/02/2019

Event Type  Injury  

Manufacturer Narrative

The product is not available for analysis.Investigation is under way.

Event Description

It was reported that a patient¿s posterior capsule was broken during implantation of an intraocular lens (iol).The iol was cut up for removal intraoperatively.The lens was exchanged for a lens of a different model and diopter.A vitrectomy was performed.The reporter is unsure why or how the capsule damage occurred, but states that there are no product quality concerns.The reporter does not have any information about the patient's current status.Though requested, no additional information was provided.

Manufacturer Narrative

The product was not returned for evaluation; consequently, no product evaluation was performed.The complaint could not be confirmed.A device history record (dhr) review could not be completed as no lot number had 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 are considered acceptable, with the product performing within anticipated rates.The root cause is unknown; however, the most probable root cause is operational context.Use of an insufficient volume of viscoelastic or not loading according to the directions for use (dfu) may result in leading haptics becoming straight during the advancement of the lens, which may result in haptic contact with the posterior capsular bag.It cannot be confirmed that the capsular damage occurred as a result of the device.All previous surgical steps including parasynthesis, capsulorhexis, phacoemulsification, and irrigation/aspiration can lead to tears in the posterior capsule.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 n. goodman; rochester NY 14609
• MDR Report Key: 9507280
• MDR Text Key: 182779367
• Report Number: 0001313525-2019-00218
• 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: user facility
• Type of Report: Initial,Followup
• Report Date: 01/01/2005,12/05/2019

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: 12/05/2019
• Initial Date FDA Received: 12/20/2019
• Supplement Dates Manufacturer Received: 02/05/2020
• Supplement Dates FDA Received: 02/25/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: NUVISC, ENVISTA TORIC INTRAOCULAR LENS
• Patient Outcome(s): Required Intervention
• Patient Age: 68 YR