MAUDE Adverse Event Report: BAUSCH + LOMB AKREOS MICROINCISION IOL; INTRAOCULAR LENS

Model Number MI60P

Device Problem Break (1069)

Patient Problems Corneal Edema (1791); Keratitis (1944)

Event Type  Injury  

Event Description

An article reported inferonasal epithelial and stromal edema encroaching onto the visual axis in the left eye of a pseudophakic patient, which did not present until six months after uncomplicated cataract surgery.The diagnosis prior to being seen by the health care facility in the article was viral keratitis.The treatment for the keratitis did not resolve the corneal edema.At referral, the patient''s vision was counting fingers, and there were no corneal findings suggestive of inflammation.Gonioscopy revealed a foreign body in the inferior iridocorneal angle which was removed under local anesthetic.Histopathological assessment of the foreign body found it to be non-organic.The intraocular lens (iol) was not noted to be decentered.The haptic of the iol became fractured at the optic haptic junction, but the lens appeared supported by the rest of the three plate haptics.Peripheral anterior capsular opacification did not allow for the haptics to be visualized in the bag.The corneal edema resolved post operatively.

Manufacturer Narrative

The device was not returned for evaluation.Additional information was requested, but not received.As a device lot number was not specified, a device history record (dhr) review could not be performed.The trend analysis, risk analysis, and directions for use are considered acceptable with the product performing within anticipated rates.Based on the available information, the root cause of this event could not be determined.Link to article: https://www.Nature.Com/articles/s41433-022-02014-5.

• Brand Name: AKREOS MICROINCISION IOL
• Type of Device: INTRAOCULAR LENS
• Manufacturer (Section D): BAUSCH + LOMB; 1400 north goodman street; 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: 15940839
• MDR Text Key: 305071440
• Report Number: 0001313525-2022-00185
• Device Sequence Number: 1
• Product Code: HQL
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: P060022
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Literature
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 11/08/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/08/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: MI60P
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• 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: VISCOJECT BIO 2.2 INJECTOR
• Patient Outcome(s): Required Intervention
• Patient Age: 84 YR