MAUDE Adverse Event Report: BAUSCH + LOMB AKREOS ADAPTAO INTRAOCULAR LENS

Model Number	ADAPTAOP
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes	Visual Impairment (2138); No Code Available (3191)
Date of Event	11/23/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
No similar events were reported for this product lot.Investigation of this event is in progress.A follow-up report will be submitted upon completion.
Event or Problem Description
It was reported that after implant of a 29.5 diopter intraocular lens (iol) the patient had post-op refraction of +7.The patient¿s vision was not satisfactory.After one (1) week the iol was explanted and replaced with a different model but same diopter iol and the patient refraction was plano.In the surgeon¿s opinion the diopter power printed on the lens packaging does not match the power of the iol.Though requested, no additional information has been received.
Additional Manufacturer Narrative
Additional information: a2, a3, b5, b7, d6, d7, d11, g4, g7, h2.No similar events were reported for this product lot.Investigation of this event is in progress.A follow-up report will be submitted upon completion.
Event or Problem Description
The original surgical procedure type was phacoemulsification with posterior chamber intraocular lens (iol) implantation.The capsulorhexis was 5.5 mm and it was well centered.Barrett and haigis formula were used for calculation of the lens power.After the secondary replacement the patient has not lost any lines of bcva compared to preoperative bcva.Patient¿s current prognosis is reportedly good outcome.
Additional Manufacturer Narrative
Although requested, the reported device was not returned for evaluation.A review of the device history records (dhr) did not find any anomalies or non-conformities related to this event.The lot history, trend analysis, risk analysis and directions for use are considered acceptable with the product performing within anticipated rates.Manufacturing records do not indicate any accountability issues or potential mixed lots.Based on the available information, the root cause of this event could not be conclusively determined.
Additional Manufacturer Narrative
Additional information: b3, b5, b6, b7, d4, g1, g2, g3, g6, h2, h6, h11.
Event or Problem Description
Additional information was located in an article titled "post cataract surgery refractive surprise due to intraocular lens mislabeling" relating to this event.It was reported that the original surgical procedure type was phacoemulsification with posterior chamber iol implantation and visco-gonio-synechia-lysis.The post replacement surgery vision was stable at 1- and 3-month appointments.

• Brand Name: AKREOS ADAPTAO INTRAOCULAR LENS
• Common Device Name: 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: 11057753
• Report Number: 0001313525-2020-00210
• Device Sequence Number: 3261022
• Product Code: HQL
• UDI-Device Identifier: 10757770486158
• UDI-Public: (01)10757770486158(17)220228
• Combination Product (Y/N): Y
• Initial Reporter Country: IR
• PMA/510(K) Number: P060022
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Device Explanted Year: 2020
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Literature,Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 12/09/2020

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: 02/28/2022
• Device Model Number: ADAPTAOP
• Device Catalogue Number: ADAPTAOP2950
• Device Lot Number: 1946318
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided; Not provided; 09/11/2024
• Initial Report FDA Received Date: 12/22/2020
• Supplement Report FDA Received Date: 01/26/2021; 02/05/2021; 10/11/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/09/2019
• 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: VISCOELASTIC OCUCOAT
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 50 YR
• Patient Sex: Female