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 Codes	Eye Injury (1845); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/15/2026
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Section d6a: if implanted, give date: not applicable, as lens was inserted and then removed in the same procedure.Section d6b: if explanted, give date: not applicable, as lens was inserted and then removed in the same procedure.Section e1.Telephone number, (b)(6).Section h3: the device was not returned for evaluation; therefore, a failure analysis of the complaint device cannot be completed.A review of records including device history and complaint trending will be performed.Upon completion of the review, if there is any further relevant information a supplemental medwatch will be filed.Attempts were made to obtain the missing information; however, no additional information has been received.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.
Event or Problem Description
It was reported that a three-piece, non-preloaded monofocal intraocular lens (iol) was noted to have one broken haptic after it was implanted in the patient¿s eye.It was subsequently removed and replaced with the same model but a different diopter (ar40e, 21.5 d).Additional information was received and stated that the iol was implanted in the patient's left eye but subsequently removed on the same procedure due to the crimped haptic and was broken upon placement.The pupil margin was also damaged upon removal.Vitrectomy was performed along with the lens replacement.Sutures were used to extend the incision.It was noted that the use of suture was not the doctor's standard practice.The removal did cause extension of the incision and the need for the suture to close.Patient injury was unknown but reported as "doing well" as per doctor.The device is not available for return.No further information was provided.
Additional Manufacturer Narrative
Additional information: additional information was received and stated that it was unknown whether any medical or surgical intervention was required or performed for the reported iris damage.No further information was provided.The following fields were updated accordingly: section h1: serious injury is added (to capture the reported damage on the pupil margin upon removal).Section h6: impact code - 4625 (additional surgery) to capture the additional treatment that was sutures.Section h6: clinical code - 1845 (eye injury) has been added to replace the code (4582 - no clinical signs, symptoms or conditions) - to capture the reported damage on the pupil margin upon removal.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: 24298708
• Report Number: 3012236936-2026-000038
• Device Sequence Number: 10165893
• Product Code: HQL
• UDI-Device Identifier: 05050474502123
• UDI-Public: (01)05050474502123(17)280527
• Combination Product (Y/N): N
• Initial Reporter State: GU
• 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): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/10/2026

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: AR40E00210
• 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: 01/15/2026
• Supplement Date Received by Manufacturer: 03/18/2026
• Initial Report FDA Received Date: 02/09/2026
• Supplement Report FDA Received Date: 04/11/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 05/27/2023
• 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 Age: 63 YR
• Patient Sex: Male
• Patient Weight: 64 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: Native Hawaiian Or Other Pacific Islander