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	04/23/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that during a surgical procedure the attempt to implant the intraocular lens (iol) was unsuccessful due to probable instability of the capsular bag, resulting in the lens dislocating and coming into contact with the posterior capsule.The iol could not be returned as it was cut and discarded.Customer indicated that the surgery was already a complication due to the after-effects of cataract, the sac was only partially present.Another lens type was placed.No intervention outside the standard of care was performed.No further information was provided.
Additional Manufacturer Narrative
Section a2, a3, a4, and a5: per regulation eu 2016/679 (general data protection regulation), patient identifiers were not collected or recorded and therefore are not available section d6a: if implanted, give date: n/a, as lens was removed/replaced during the same procedure.Section d6b: if explanted, give date: n/a, as lens was removed/replaced during the same procedure.Section e1 - telephone number: (b)(6) section h6 -health effect - clinical code: 4581 no code available (device dislocation) section h3: the device was not returned for evaluation as it was discarded; therefore, a failure analysis of the complaint device cannot be completed.A review of the device history record, complaint trending for this device will be performed.Upon completion of the review, if there is any further relevant information a supplemental medwatch will be filed.Attempts have been made to obtain missing information.However, to date, no response has been received.All pertinent information available to johnson and 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: 25232309
• Report Number: 3012236936-2026-000120
• Device Sequence Number: 10356767
• Product Code: HQL
• UDI-Device Identifier: 05050474502086
• UDI-Public: (01)05050474502086(17)290917
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• PMA/510(K) Number: P980040
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 05/20/2026

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: AR40E00190
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/24/2026
• Initial Report FDA Received Date: 05/20/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 09/16/2024
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown