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

Model Number	AR40E
Medical Device Problem Codes	Material Fragmentation (1261); Ejection Problem (4009)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/01/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Section a2, a3a, a3b, a4, a5, a6, patient information: not provided due to personal data privacy legislation/policy.Section d6a, if implanted, give date: not applicable.There is no indication the lens was implanted.Section d6b, if explanted, give date: not applicable.There is no indication the lens was implanted.Therefore, it was not explanted.Device evaluation: product evaluation was not performed because the product has not been received.The complaint issue reported could not be confirmed.Manufacturing record review: the manufacturing records for the product were reviewed.The product was manufactured and released according to specifications.A search of complaints related to this production order (po) was performed.The search revealed one additional complaint folder was received for this po.Although this complaint issue reported is related, the issue could not be confirmed as related to manufacturing.Therefore, no further actions are required.Conclusion: based on the investigation, no malfunction or product deficiency was identified.Attempts have been made to obtain the missing information.However, to date, the information has not been received.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.
Event or Problem Description
It was reported that the physician folded a non-preloaded monofocal intraocular lens (iol) and initiated insertion when the haptic broke off.The lens was partially inserted at the time of the event.The device was removed without the need for unplanned incision enlargement, sutures, or additional medical treatment beyond standard of care.There was no procedural delay, and the directions for use were followed.Patient outcome is unknown.No further information was provided.The issue reported with two lenses; this report pertains to one of the two.A separate report was submitted for the other lens.

• 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: 25075997
• Report Number: 3012236936-2026-000120
• Device Sequence Number: 21519446
• Product Code: HQL
• UDI-Device Identifier: 05050474501942
• UDI-Public: (01)05050474501942(17)290202
• 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
• 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): 05/05/2026

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: AR40E00120
• 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: 04/08/2026
• Initial Report FDA Received Date: 05/04/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/02/2024
• 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
• Concomitant Medical Products and Therapy/Usage Dates: CARTRIDGE, MODEL/LOT: UNKNOWN.
• Patient Sex: Unknown