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

Model Number AI-28

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem No Code Available (3191)

Event Date 01/20/2021

Event Type  Injury  

Manufacturer Narrative

The device was not returned for evaluation.As the lot number is unknown, the associated device history record was unable to be reviewed.A review of nonconformances found no similar events that would have contributed to the reported event.The trend analysis, risk analysis, and directions for use are considered acceptable with the product performing within anticipated rates.User related factors (such as loading or handling techniques) and/or procedural factors (such as lens and inserter interaction) may have contributed to the event as the reporter stated the most likely cause of the damage was a loading error.

Event Description

It was reported that during a phacoemulsification surgery to implant an intraocular lens (iol) into the left (os) eye, the iol was difficult to deliver and appeared to be stuck in the delivery device.As the iol was implanted into the eye, the surgeon noticed the iol was cracked.The incision was enlarged to 4.0mm to remove the lens.A successful intraoperative lens exchange was performed using a back up lens of the same model and diopter.10.0 nylon sutures were used.The plan of surgery was changed as the incision was enlarged and sutures were required.In the physician''s opinion, the most likely cause of the damage was a loading error.The patient did not notice a decrease in vision and has improved post-operatively and even more at the follow up visit.Patient''s prognosis is good.

• Brand Name: BAUSCH + LOMB IOL INJECTOR
• Type of Device: FOLDERS AND INJECTORS, INTRAOCULAR LENS (IOL)
• Manufacturer (Section D): BAUSCH + LOMB; 1400 north goodman street; rochester NY 14609
• Manufacturer (Section G): MEDICEL AG; dornierstrasse 11; altenrhein CH ¿ 9423; SZ CH ¿ 9423
• Manufacturer Contact: stephanie anastasiou ; 21 n park place blvd; clearwater, FL 33759 ; 7277246659
• MDR Report Key: 11348042
• MDR Text Key: 232548421
• Report Number: 0001313525-2021-00022
• Device Sequence Number: 1
• Product Code: MSS
• Combination Product (y/n): Y
• Reporter Country Code: US
• PMA/PMN Number: K113852
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 01/21/2021

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: AI-28
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 02/19/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: AKREOS INTRAOCULAR LENS, DUOVISC VISCOELASTIC
• Patient Outcome(s): Required Intervention
• Patient Age: 70 YR