MAUDE Adverse Event Report: AMO PUERTO RICO MFG. INC. SENSAR IOL; INTRAOCULAR LENS

Model Number	AR40E
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	10/17/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a non preloaded, monofocal intraocular lens (iol) with a diopter of +3.0d+3.0d was implanted in the patient¿s right eye.During a post operative examination the lens was observed to be displaced and decentered due to one haptic failing to hold.The lens was explanted and replaced with another lens of the same model and diopter (+3.0d+3.0d).There was no recent eye trauma or history of conditions known to weaken the natural lens support.There was also no indication of residual viscoelastic material remaining after the original surgery that might have caused early movement, and no surgical maneuvers outside the normal standard of practice were required to deliver or position the original lens.There was no surgical delay and no complications such as incision enlargement, sutures, or vitrectomy reported.No additional medical attention or medication beyond the standard of care was required, and the patient¿s daily activities were not affected.The patient has fully recovered, and the replacement lens was properly positioned on post op day 1.The explanted lens was discarded and will not be returned.Directions for use were followed.During device preparation a balanced salt solution (bss) acclimatized to operating room temperature was used to fill the entire inside of the cartridge.No further information was provided.
Additional Manufacturer Narrative
Section h3: the device was not returned for evaluation as it discarded; therefore, a failure analysis of the complaint device cannot be completed.A review of the device history record and complaint history for production order for this device will be performed.Upon completion of the review, if there is any further relevant information a supplemental medwatch will be file.Section h6- health effect - clinical code 4581 - this code is used to capture device decentered or dislocated or tilted subluxated or wrong position.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.

• Brand Name: SENSAR IOL
• Common Device Name: INTRAOCULAR LENS
• Manufacturer (Section D): AMO PUERTO RICO MFG. INC.; road 402 north, anasco ind. pk; anasco PR 00610
• Manufacturer Contact: somyata nagpal ; 31 technology drive; irvine, CA 92618 ; 7142478552
• MDR Report Key: 23547898
• Report Number: 3012236936-2025-000294
• Device Sequence Number: 13092087
• Product Code: HQL
• UDI-Device Identifier: 05050474501850
• UDI-Public: (01)05050474501850(17)300809
• Combination Product (Y/N): N
• Initial Reporter State: WI
• Initial Reporter Country: US
• PMA/510(K) Number: P980040
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• Device Explanted Year: 2025
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 11/13/2025

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?: Yes
• Operator of Device: Health Professional
• Device Model Number: AR40E
• Device Catalogue Number: AR40E00030
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/20/2025
• Initial Report FDA Received Date: 11/13/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 08/09/2025
• 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: ALCON BSS
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 66 YR
• Patient Sex: Female
• Patient Weight: 68 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White