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

Model Number	LI61AOR
Medical Device Problem Codes	Break (1069); Material Split, Cut or Torn (4008)
Health Effect - Clinical Codes	Macular Edema (1822); Blurred Vision (2137); Capsular Bag Tear (2639); Vitrectomy (2643); No Code Available (3191)
Date of Event	12/23/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The lens remains implanted and is not available for evaluation.The investigation is ongoing.
Event or Problem Description
It was reported that while inserting the intraocular lens (iol) the end of the leading haptic broke off.The surgeon was able to remove the piece of haptic, but the surgeon reports it caused rip in the posterior capsular bag with loss of vitreous, requiring a vitrectomy.The iol was placed in the ciliary sulcus instead of the capsular bag, which was a change in the surgery plan.The iol damage was observed intraoperatively.The surgeon believes the iol is defective.The incision was not enlarged, and no sutures were required.The lens remains implanted.The patients vision appears to be recovering well.There is still vitreous in the anterior chamber, so the surgeon is concerned about the development of cystoid macular edema.The patient will be returning for a final postoperative evaluation.
Additional Manufacturer Narrative
As it remains implanted, the lens is not available for evaluation.The lot history, trend analysis, risk analysis and directions for use review are considered acceptable, with the product performing within anticipated rates.Manufacturing, inspection, and test records indicate that the lens conformed to specification at the time of release.There have been no other complaints for this lot to date.Based on the information provided we are unable to determine a root cause.No corrective action is necessary at this time.
Event or Problem Description
Upon the final post-operative evaluation, the patient¿s visual acuity was correctable to the 20/20-20/25 range.No additional intervention is necessary.The patient still has pupil peaking where the vitreous band exists from behind the pupil and extends anteriorly toward the side-port incision.This does not appear to cause the patient any problems at this time.The surgeon noted that if it was to cause any issues such as cystoid macular edema, the surgeon would attempt severing the vitreous band with a yag laser procedure.
Event or Problem Description
Additional information received from the consumer indicated that approximately two years after intraocular lens (iol) implant into the left (os) eye, the consumer continued to experience blurry vision, floaters, headaches, photophobia, and photopsia.Approximately, one year and 11 months after original implant, patient underwent a successful yag.Approximately two years after implant, the patient was seen for consultation by a different physician presenting with blurry vision, floaters, photophobia and photopsia.Physician noted that the patient presented with increasing eye discomfort, increased anterior chamber inflammation, keratitic precipitate, and cystoid macular edema (cme).During three week follow up appointment, patient presented with significantly improved inflammation and cme, but symptoms persisted.Patient was much more comfortable.Physician was concerned that the iol has shifted position and causing inflammation and referred patient to another physician for evaluation of dislocated lens in the setting of macular edema.Referring physician''s assessment was a dislocated iol and vitreous present in the anterior chamber to the cornea.The lens was quite anterior in the sulcus and potentially inducing inflammation from iris chafing.Patient presented with persistent cme and anterior uveitis after yag.A successful lens exchange using a different model lens and a vitrectomy was performed approximately 2 years and 4 months after original iol implant.In the surgeon''s opinion, the most likely cause of the event was the orientation of the iol changed causing anterior uveitis.Reportedly, after iol exchange, symptoms resolved except for the loss of vision, which has continued to decline to a point that the consumer cannot read anything with the left eye.During most recent appointment with physician, consumer was informed vision was worsening, the intraocular pressure was increasing, and there was neovascularization of the iris; however according to the information provided by the surgeon, the patient outcome was good.Additional information, was requested and not received.
Event or Problem Description
Additional information received from ophthalmologist provides the patient is being referred back to the surgeon that completed lens exchange.
Additional Manufacturer Narrative
Additional information: b5, b6, b7, g3, h2, h10/11.

• Brand Name: SOFPORT AO INTRAOCULAR LENS
• Common Device Name: INTRAOCULAR LENS
• Manufacturer (Section D): BAUSCH + LOMB; 1400 n. goodman; rochester NY 14609
• Manufacturer (Section G): BAUSCH + LOMB; 21 north park place blvd.; clearwater FL 33759
• Manufacturer Contact: shayan habibi ; 21 north park place blvd.; clearwater, FL 33759 ; 7277246600
• MDR Report Key: 9615679
• Report Number: 0001313525-2020-00009
• Device Sequence Number: 16824803
• Product Code: HQL
• UDI-Device Identifier: 10757770474384
• UDI-Public: (01)10757770474384(17)240630
• Combination Product (Y/N): Y
• Initial Reporter State: MN
• Initial Reporter Country: US
• PMA/510(K) Number: P910061
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 12/23/2019
• Report Date (Section F): 01/01/2005

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
• Operator of Device: Health Professional
• Device Expiration Date: 06/30/2024
• Device Model Number: LI61AOR
• Device Catalogue Number: LI61AOR2350
• Device Lot Number: 4955802
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report to Manufacturer: 01/10/2005
• Initial Date Received by Manufacturer: 12/23/2019
• Supplement Date Received by Manufacturer: 03/04/2020; 03/04/2020; 03/04/2020
• Initial Report FDA Received Date: 01/22/2020
• Supplement Report FDA Received Date: 03/31/2020; 06/01/2023; 06/27/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 07/12/2019
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: EZ-28V INSERTER, HEALON VISCOELASTIC.; MCPHERSON FORCEPS.
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 66 YR
• Patient Sex: Male
• Date Report Sent to FDA: 01/01/2005