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	07/14/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the non-preloaded monofocal intraocular lens (iol) was implanted in the patient's operative eye; however, following implantation, it was noted that the lens had a broken haptic.An ar40 12.0d lens was ordered, and a lens exchange was planned.Through follow up we learned that the lens was explanted on (b)(6) 2026.However, the surgeon decided to postpone implantation of a replacement lens, as the eye was not in a suitable condition to receive a new iol at that time.No additional information was provided.
Additional Manufacturer Narrative
Section a2, a3a, a3b, a4 and a5: per regulation eu 2016/679 (general data protection regulation), patient identifiers were not collected or recorded and therefore are not available.Section e1 - telephone number: (b)(6).Device evaluation: visual inspection of the complaint device reveal that the lens was received coated in an unknown liquid.The lens was cleaned revealing the lens was damaged; both haptics were also observed to be damaged.The complaint issue "haptic damaged" was identified during product evaluation.However, based on the complaint investigation results, the complaint issue and other observations made during product evaluation could not be confirmed to be related to the manufacturing or design process.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.Section h6- health effect - impact code: 2199 - this code is used to capture incomplete treatment.Section h6- health effect - clinical code 4581 - this code is used to capture incomplete treatment.All pertinent information available to johnson and 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: 50211697
• Report Number: 3012236936-2026-000213
• Device Sequence Number: 15954776
• Product Code: HQL
• UDI-Device Identifier: 05050474501935
• UDI-Public: (01)05050474501935(17)290425
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: P980040
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2026
• Device Explanted Year: 2026
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/13/2026

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: AR40E00110
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 07/28/2026
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/14/2026
• Supplement Date Received by Manufacturer: 08/12/2026
• Initial Report FDA Received Date: 08/11/2026
• Supplement Report FDA Received Date: 08/13/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/25/2024
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown