MAUDE Adverse Event Report: BAUSCH + LOMB S122UV ANTERIOR CHAMBER PMMA LENS; INTRAOCULAR LENS

Model Number S122UV

Device Problems Adverse Event Without Identified Device or Use Problem (2993); Patient Device Interaction Problem (4001)

Patient Problems Macular Edema (1822); Glaucoma (1875); Pain (1994); Blurred Vision (2137); Visual Impairment (2138); Vitrectomy (2643); No Code Available (3191)

Event Date 10/07/2019

Event Type  Injury  

Manufacturer Narrative

Investigation of this event is in progress, results pending completion of the investigation.According to the reporter, the lens is not available for evaluation.

Event Description

It was reported that the patient experienced a poorly tolerated anterior chamber intraocular lens (ac iol); the implant date is unknown.The patient complained of decrease in vision, blurry vision, double vision and light sensitivity of the left eye.Patient underwent an iol exchange, pars plana vitrectomy was performed due to no support, vitreous strands.Iris repair and limbal relaxation incision of the left eye for astigmatism.Orientation of lens did not change.Iol was clear and free of debris/deposits.In the surgeon's opinion the likely cause of the event was due to the patient being unable to tolerate an anterior chamber iol.During the original surgery an ac lens was implanted due to loss of support.Patient reported to be doing "excellent.".

Manufacturer Narrative

According to the reporter, the lens is not available for evaluation.During the original surgery an anterior chamber (ac) lens was implanted due to loss of support.The ac lens was intolerable because of cme (cystoid macular edema), glaucoma, pain and glare.As per the medical reviewer¿s assessment; lri (limbal relaxation incision) is a partial thickness corneal incision strategically placed to reduce or eliminate a pre-existing astigmatism, during cataract surgery or refractive lens exchange surgery.As the surgeon proceeded with the lri, the lens was also exchanged for one diopter stronger.The most likely cause of patient''s visual complaint and lens intolerability was due to a refractive error.The lot history, trend analysis, risk analysis and directions for use review are considered acceptable, with the product performing within anticipated rates, and 100% of lenses passing power inspection.There have been no other complaints for this lot, and there have been no other complaints received for this reason in the previous fourteen months.The most probable root cause is "patient related".This appears to be an isolated incident, and no corrective action is necessary at this time.

• Brand Name: S122UV ANTERIOR CHAMBER PMMA LENS
• Type of Device: INTRAOCULAR LENS
• Manufacturer (Section D): BAUSCH + LOMB; 1400 north goodman st.; rochester NY 14609
• MDR Report Key: 9491071
• MDR Text Key: 182723153
• Report Number: 0001313525-2019-00212
• Device Sequence Number: 1
• Product Code: HQL
• Combination Product (y/n): Y
• PMA/PMN Number: P880090
• 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: 01/01/2005,12/02/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/18/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 04/30/2020
• Device Model Number: S122UV
• Device Catalogue Number: S122UV1450
• Device Lot Number: 2549017
• 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
• Date Manufacturer Received: 01/07/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 75 YR