MAUDE Adverse Event Report: BAUSCH + LOMB SOFPORT AO INTRAOCULAR LENS

Model Number LI61AO

Device Problem Failure to Unfold or Unwrap (1669)

Patient Problems Vitrectomy (2643); No Code Available (3191); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 01/23/2021

Event Type  Injury  

Manufacturer Narrative

According to the reporter, the lens was discarded and is not available for evaluation.Investigation of this event is in progress.Upon completion of investigation, a follow-up report will be submitted.

Event Description

The physician attempted to inject an intraocular lens in the patient''s eye and allegedly, the haptic did not open and remained stuck to the lens.In order to remove the lens, the incision was enlarged, an anterior vitrectomy followed by sutures was performed.Surgery time was also extended.The physician successfully loaded a replacement lens of unknown model and diopter but decided not to implant.It is unclear why the patient is left aphakic.A follow up appointment is scheduled.Additional information has been requested and not received.

Event Description

Additional information received indicating that the patient had high intraocular pressure two days after surgery and was sent home with more medication.Patient is to have another iol implanted in the future.

Manufacturer Narrative

Although requested, the lens was not returned for evaluation.The lot history, trend analysis, risk analysis and directions for use review were considered acceptable, with the product performing within anticipated rates.Additional information has been requested and not received.Based on the information provided a root cause for the reported event could not be conclusively determined.

• Brand Name: SOFPORT AO INTRAOCULAR LENS
• Type of Device: INTRAOCULAR LENS
• Manufacturer (Section D): BAUSCH + LOMB; 1400 north goodman street; rochester NY 14609
• MDR Report Key: 11371566
• MDR Text Key: 233246356
• Report Number: 0001313525-2021-00024
• Device Sequence Number: 1
• Product Code: HQL
• Combination Product (y/n): Y
• PMA/PMN Number: P910061
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign,health pr
• Type of Report: Initial,Followup
• Report Date: 01/25/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/24/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: LI61AO
• Device Catalogue Number: LI61AOR1850
• Device Lot Number: 222
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 03/04/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: SOFPORT EASYLOAD LENS DELIVERY SYSTEM; SOFPORT EASYLOAD LENS DELIVERY SYSTEM
• Patient Outcome(s): Required Intervention