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

Model Number INJ100

Device Problems Mechanical Problem (1384); Use of Device Problem (1670)

Patient Problems Corneal Perforation (1792); No Code Available (3191)

Event Date 03/23/2020

Event Type  Injury  

Manufacturer Narrative

The delivery device was not returned for evaluation; therefore, a product evaluation could not be performed, and the reported complaint could not be confirmed.As no lot number was provided for the delivery device a review of the device history record (dhr) could not be performed.A review of the complaint trend determined that 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 reported appearance is a typical effect when surgeon continues to push the plunger after the intraocular lens (iol) has exited.The length of the plunger is correct.The length of the plunger is chosen so that the iol can be delivered under all circumstances, even if the user does not follow the mandatory directions for use (dfu) requirements.If the plunger is shorter, the iol can be half outside and half-in the tip, and this scenario is considered a worst case scenario.Other causes of an inflated tip can be caused by a pumping advance of the plunger or a trapped trailing haptic.Based on the available information the most probable root cause for the event is user error.No corrective action is necessary at this time.

Event Description

It was reported that during a phacoemulsification cataract surgery on the patient's right eye that following deployment of the intraocular lens (iol) the silicone plunger on the injector advanced all the way out through the opening on the cartridge.This reportedly tore the patient¿s cornea as they previously has a radial keratotomy (rk) refractive surgery procedure.The plunger would not retract into the cartridge and due to the mushroom shape the injector could not be removed from the patient¿s eye.The surgeon unsuccessfully attempted to push the plunger into the cartridge using an iris repository.To remove the injector from the patient¿s eye the surgeon cut the mushroom flares off the plunger.According to the reporter removing the injector from the eye resulted in an extension of the patient''s rk¿s which required corneal suturing and air injection to seal the eye.The surgeon stated that the plunger should not be able to prolapse through the cartridge, and if it does, is should be able to retract back into it.This would have avoided this complication the phacoemulsification cataract surgery was not complicated in any way.The orientation of the iol did not change.The optic of the iol is clear and free of debris and deposits.The iol was implanted successfully and is not related to this adverse event.The patient noticed a decrease in their vision as early post-operative vision is reduced due to air bubble and possibly slight astigmatism induced.Patient¿s current prognosis is good but corneal sutures will need to be removed.Additional information has been requested but has not been received.

Manufacturer Narrative

A distribution trace of lot numbers shipped to healthcare facility from (b)(6) 2019 identified four (4) possible lot numbers.The potential lot numbers were identified as lot 1822c2 (manufacturing date: 15 may 2018, expiration date: 30th april 2020), lot 1822b3 (manufacturing date: 16th july 2018, expiration date: 30th june 2020), lot 1822f4 (manufacturing date: 7th july 2018, expiration date: 30th june 2020), and lot 1844m6 (manufacturing date: 5th february 2019, expiration date: 30th january 2021).A dhr review was performed for the lot numbers and it was found that all validated processes and procedures were followed.No deviation or non-conformity was noted.The conclusions from our previous report remain unchanged.

• Brand Name: BAUSCH + LOMB VIS100 INJECTOR SYSTEM
• Type of Device: FOLDERS AND INJECTORS, INTRAOCULAR LENS (IOL)
• Manufacturer (Section D): BAUSCH + LOMB; 1400 north goodman street; rochester NY 14609
• MDR Report Key: 9983289
• MDR Text Key: 188580837
• Report Number: 0001313525-2020-00076
• 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: foreign,health professional,u
• Type of Report: Initial,Followup
• Report Date: 01/01/2005,03/24/2020

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: INJ100
• 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: 03/24/2020
• Initial Date FDA Received: 04/21/2020
• Supplement Dates Manufacturer Received: 04/28/2020
• Supplement Dates FDA Received: 05/25/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: IOL-AKREOS (ADAPTAOP2650)
• Patient Outcome(s): Required Intervention
• Patient Age: 73 YR