MAUDE Adverse Event Report: AMO Puerto Rico Mfg. Inc. SENSAR IOL; Intraocular Lens

Model Number	AR40e
Medical Device Problem Code	Material Fragmentation (1261)
Health Effect - Clinical Codes	Capsular Bag Tear (2639); Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/19/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that two non-preloaded monofocal intraocular lenses (iols) were associated with complications during a surgical procedure involving the patient's right eye.The first lens (ar40c +23.5, sn (b)(6)) was the initial lens used.During implantation, a superior haptic was reported to be broken.The lens was not fully inserted into the patient's eye when the issue was identified.The second lens (ar40c +24.0, sn (b)(6)) was then implanted; however, disinsertion of the posterior haptic was observed.This lens was fully inserted into the patient's eye and subsequently removed.Additional information indicated that a capsular rupture occurred and that an unplanned anterior vitrectomy and incision enlargement were performed during the procedure.However, it is unknown at what point during the procedure the capsular rupture occurred or whether the vitrectomy and incision enlargement were associated with the first lens, the second lens, or another aspect of the procedure.No sutures were required.No replacement lens was implanted following removal of the lenses, and the patient remained aphakic.No cartridge tip damage or use error was reported.It was indicated that the device did not cause or contribute to the event.No further information was available.This mdr report captures the issues reported with the first lens.A separate report will be submitted for the issues reported with the second lens.
Additional Manufacturer Narrative
Section a4, a5 and a6: unknown, information was requested but not provided.Section d6a.If implanted, give date: unknown, information not provided.Section d6b.If explanted, give date: not applicable, as there is no indication that the device was explanted.Section e1: initial reporter establishment name: unknown, information not provided.Section e1: initial reporter's address, city, state and zip code: unknown, information not provided.Section e1: phone number: (b)(6) device evaluation: the product testing could not be performed as the product was not returned for evaluation.The reported complaint cannot 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 that no other complaints were received for this production order number.Conclusion: based on the investigation, no malfunction or product deficiency was identified.Section h6: health effect - impact code: 4625 - additional surgery (incision enlarged & unplanned vitrectomy) section h6: health effect - clinical code: 4581 incision enlarged.Attempts were made to obtain additional information regarding the event; however, the information was not provided.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.This report was impacted by emdr scheduled maintenance occurring july 22-27, 2026.

• 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 ; +1(714)247-8552
• MDR Report Key: 50047507
• Report Number: 3012236936-2026-000215
• Device Sequence Number: 10628377
• Product Code: HQL
• UDI-Device Identifier: 05050474502178
• UDI-Public: (01)05050474502178(17)310113
• 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): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 07/27/2026

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: AR40E00235
• 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: 07/02/2026
• Initial Report FDA Received Date: 07/27/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/13/2026
• 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: Male