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 Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/31/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that a non-preloaded monofocal intraocular lens (iol) was inserted into the patient's left eye and, during the implantation procedure, both haptics broke off inside the eye.The iol was subsequently removed and replaced with another lens of the same model and diopter power.No unplanned vitrectomy or additional medical intervention outside the standard of care was reported.It is unknown whether unplanned sutures were required or whether the procedure was delayed.The patient outcome was unknown.It was noted that the lens was discarded.No further information was provided.
Additional Manufacturer Narrative
Section a4 and a5: unknown, information was requested but not provided.Section d6a: if implanted, give date: not applicable, as lens was removed/replaced during the same surgery.Section d6b: if explanted, give date: not applicable, as lens was removed/replaced during the same surgery.Device evaluation: product evaluation was not performed because the product was not received (the lens was discarded).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 that no other complaints were received for this po.Conclusion: based on the investigation, no malfunction or product deficiency was identified, and the reported complaint issue could not be confirmed.Attempts have been made to obtain missing information; however, to date, the information has not been provided.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 ; +1(714)247-8552
• MDR Report Key: 50892878
• Report Number: 3012236936-2026-000280
• Device Sequence Number: 13439818
• Product Code: HQL
• UDI-Device Identifier: 05050474502123
• UDI-Public: (01)05050474502123(17)310620
• Combination Product (Y/N): N
• Initial Reporter State: MT
• 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): 09/25/2026

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: 09/01/2026
• Initial Report FDA Received Date: 09/25/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/20/2026
• 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
• Patient Sex: Male
• Patient Race: American Indian Or Alaskan Native