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

Model Number BLIS-X1

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

Patient Problems No Code Available (3191); Unspecified Eye / Vision Problem (4471)

Event Date 12/08/2020

Event Type  Injury  

Manufacturer Narrative

Per the reporting facility, the device is not available for return.No device evaluation can be performed.The investigation is ongoing.

Event Description

It was reported that during a phacoemulsification surgery to implant an intraocular lens (iol) into the right (od) eye, the haptic tore after implant.The surgeon enlarged the original incision of 2.4mm to 4.4mm and performed a successful intraoperative lens exchange using a back up lens of the same model, but different diopter.10-0 nylon sutures were used.In the surgeon's opinion, the lens was torn at the back haptic as it was being delivered through the injector cartridge.The patient did not notice a decrease in vision and is doing well, but there is residual cylinder.The patient's outcome is good.

Manufacturer Narrative

A device history record (dhr) review could not be done, as no lot number had been provided.The product was not returned for evaluation.Consequently, no product evaluation had been performed.The lot history, trend analysis, risk analysis and directions for use review are considered acceptable, with the product performing within anticipated rates.The most probable root cause for this event is user error.Loading of the iol is essential for the performance of the injector and its cartridge.Issues during the loading process may lead to damaged haptics if the loading instructions are not properly followed.

• 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: 11122955
• MDR Text Key: 225263374
• Report Number: 0001313525-2021-00002
• 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: distributor
• Type of Report: Initial,Followup
• Report Date: 12/08/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/06/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: BLIS-X1
• Device Catalogue Number: BLIS-X1
• Device Lot Number: 222
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 02/19/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: ENVISTA TORIC IOL, AMVISC VISCOELASTIC; ENVISTA TORIC IOL, AMVISC VISCOELASTIC
• Patient Outcome(s): Required Intervention
• Patient Age: 57 YR