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

Model Number	AR40E
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/07/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Section a3b, a4, and a5 (race): information was requested but it is unknown/ not provided.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).Device evaluation: product testing could not be performed since the device was not returned for evaluation.Therefore, the reported issue could not be verified, and no product quality deficiency could be identified.Manufacturing records review: the manufacturing records for the product were reviewed.The product was manufactured and released according to specification.A search of complaints related to this production order (po) was performed.The search revealed that no additional complaints were received for this po.No escalation required.Conclusion: as a result of the investigation there is no indication of a product quality deficiency and the reported issue could not be verified.All pertinent information available to johnson & johnson surgical vision, inc has been submitted.
Event or Problem Description
It was reported that during a cataract surgery a capsule rupture occurred requiring an anterior vitrectomy.A sensar 3-piece intraocular lens (iol) was implanted in the patient's right eye.Despite being correctly assembled in the cartridge, the haptic of the lens was found to be broken.The lens was replaced during the same surgical procedure with another lens of identical characteristics.The patient was reported to be in good postoperative condition, and no additional medication beyond the standard of care was administered.No further medical or surgical interventions were planned.No further information provided.
Additional Manufacturer Narrative
Additional information: section d9.Device available for evaluation? yes.Returned to manufacturer on jan 26, 2026.Section h3.Device evaluated by manufacturer? yes.Device evaluation: the product was returned to the manufacturing site for evaluation.Visual inspection under magnification was performed on the suspect product and found the lens was coated in viscoelastic residue.The lens was cleaned revealing damage and a tear at the edge.A haptic was observed to be detached.The lens was forwarded to the manufacturing site for haptic drill hole measurement and was found to be within specifications.The complaint issue "haptic damage" was not identified during product evaluation.The observed "haptic detached" is similar to the reported complaint issue.However, based on the complaint investigation results the complaint issue could not be confirmed to be related to the manufacturing or design process.Based on the complaint investigation results, the product was released within specifications.No product deficiency or product malfunction could be identified.Conclusion: as a result of the investigation there is no indication of a product quality deficiency and the reported issue could not be verified.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: 23348496
• Report Number: 3012236936-2025-000274
• Device Sequence Number: 18527909
• Product Code: HQL
• UDI-Device Identifier: 05050474502130
• UDI-Public: (01)05050474502130(17)300114
• Combination Product (Y/N): N
• Initial Reporter Country: CO
• PMA/510(K) Number: P980040
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 02/27/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: AR40E
• Device Catalogue Number: AR40E00215
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• 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: 09/22/2025
• Supplement Date Received by Manufacturer: 02/10/2026
• Initial Report FDA Received Date: 10/21/2025
• Supplement Report FDA Received Date: 02/27/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/14/2025
• 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
• Patient Sex: Female
• Patient Ethnicity: Hispanic