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

Model Number LI61AOR

Device Problems Patient-Device Incompatibility (2682); Device Dislodged or Dislocated (2923)

Patient Problems Eye Injury (1845); Vitrectomy (2643); No Code Available (3191)

Event Date 08/01/2019

Event Type  Injury  

Manufacturer Narrative

The lens remains implanted and is not available for evaluation.There have been no other complaints for this lot to date.The lot history, trend analysis, risk analysis and directions for use review are considered acceptable, with the product performing within anticipated rates.There are no open nonconformances for this complaint type.According to the medical review the patient has zonular dialysis, a risk factor for lens dislocation.The most probable root cause is "patient related".No corrective action necessary at this time.Further information has been requested from the implanting surgeon.Should this information be received, a follow up report will be submitted.

Event Description

A patient experienced blurry vision and glare of the right eye four months post intraocular lens (iol) implant.The patient was referred by the implanting doctor to another surgeon, who found the iol to be dislocated.Additionally, an iris defect was observed upon initial consultation with the referred surgeon.It is unclear when this iris defect presented.Additional information has been requested from the implanting surgeon but has not been received.The iol optic remained clear and free of debris/deposits.The patient underwent an iol repositioning 4.5 months post implant as a result of the dislocation.The rotation occurred between the anterior and posterior bag.The incision was not enlarged, and sutures were not required.An iris repair was also necessary due to the observed defect in the iris.The surgeon had to dissect the iris out of the incision and suture it closed.It could be seen that there was vitreous coming around a zonular dialysis infratemporally to the main incision, where the iris was tented up.A pars plana vitrectomy was carried out to remove the anterior vitreous.The patient was compliant with the prescribed postoperative anti-inflammatory medications.The patient now states that their vision is not as blurry, and glare has decreased.In the surgeon's opinion, the likely cause of the dislocation is fibrosis.

Manufacturer Narrative

No similar events have been reported for this lot number.In the medical reviewer¿s opinion, the event seems more likely related to the iris defect which occurred during the first procedure (with a lens of a different manufacturer) and not related to the following two lenses implanted.The conclusions from our previous report remain unchanged.

Event Description

Additional information has been received from the implanting surgeon.The patient has had two od lens exchanges.The patient¿s initial intraocular lens was a different model manufactured by another company.The patient presented with blurry vision post implant of the original lens and was sent to a cornea specialist.The specialist observed an illumination of the implant and a slight opacity.The implant had wound leakage and the iris went to the wound.The implanting surgeon suspects that there was a quality issue with the original lens (manufactured by another company).The original lens was explanted and replaced with the same model as the reported lens, which was minimally decentered upon implantation.The implanting doctor has no product quality concerns for the reported lens.The patient was compliant with postoperative anti-inflammatory medications after the implanting surgery.The patient was referred to another surgeon [the reporting surgeon who explanted the lens] due to the iris defect.The implanting surgeon had no information about the patient¿s fibrosis, zonular dialysis infratemporally.The implanting surgeon did not observe much fibrosis, and only noted that the pupil was teardrop shaped and needed to be repaired.The implanting surgeon did not see significant decentration of the reported lens.According to the implanting surgeon, the explanting surgeon observed more decentration after the iris repair and decided on a lens exchange at that time.The explanting surgeon had informed the implanting surgeon that the edge of the lens could be seen and was tilted in the location that the iris was retracted.According to the implanting surgeon, the explanting surgeon was concerned that this could cause asymmetrical force.The explanting surgeon had tried to open the fibrosis to attempt reposition of the lens, but when he was not able to get it open he explanted the lens and replaced it with the reported lens.

• Brand Name: SOFPORT AO INTRAOCULAR LENS
• Type of Device: INTRAOCULAR LENS
• Manufacturer (Section D): BAUSCH + LOMB; 1400 n goodman; rochester NY 14609
• MDR Report Key: 9296105
• MDR Text Key: 182776444
• Report Number: 0001313525-2019-00181
• 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: health professional,user faci
• Type of Report: Initial,Followup
• Report Date: 01/01/2005,10/10/2019

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 Expiration Date: 11/30/2023
• Device Model Number: LI61AOR
• Device Catalogue Number: LI61AOR1300
• Device Lot Number: 4871208
• 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: 10/10/2019
• Initial Date FDA Received: 11/08/2019
• Supplement Dates Manufacturer Received: 11/22/2019
• Supplement Dates FDA Received: 12/20/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 73 YR