MAUDE Adverse Event Report: AMO Puerto Rico Mfg. Inc. PureSee IOL; LENS, INTRAOCULAR, TORIC OPTICS

Model Number	DET150
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Visual Disturbances (2140); Halo (2227)
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a patient implanted bilaterally with preloaded extended depth of focus (edof) toric intraocular lenses (iols) experienced significant postoperative halos and glare.During a postoperative examination, the physician reported a plano refractive outcome in one eye and slight myopia in the fellow eye; however, the patient's visual symptoms persisted over time.The physician indicated that the cause of the symptoms was uncertain but suggested that they may be related to the implanted lenses.Additional information indicated that the left-eye (os) lens was explanted on (b)(6) 2026, due to the reported visual symptoms and was replaced with a zcu lens.The physician further reported that explantation of the fellow-eye lens was planned for the following week.Subsequent follow-up revealed that the right-eye (od) lens was also explanted.The date of the explant procedure was not provided.No additional information regarding the procedure, replacement lens for the right eye, or patient outcome following the explant was available.No further information was provided.This report captures the issues reported with the patient's right eye.A separate report will be submitted for the patient's left eye.
Additional Manufacturer Narrative
Section a4, a5 and a6: unknown, information was requested but not provided.Section b3: date of event: unknown, not provided, but the best estimate date is on or after jun 15, 2026.Section d6b: if explanted, give date: unknown; information was requested but not provided.Section h6: health effect - impact code: 4619 - temporary impairment (this code is used for the reported halo vision- surgical intervention required, glare surgical intervention required issues).Device evaluation: the device was not returned at the manufacturing site; therefore, product testing could not be performed and the customer¿s reported complaint could not be verified.Manufacturing record review: the manufacturing records for the intraocular lens were reviewed.The product was manufactured according to specifications.A search of complaints related to this production order (po) was performed.The search of complaints revealed that no similar complaint for this production order number has been received.Conclusion: as a result of the investigation there is no indication of a product quality deficiency, and the reported issue could not be confirmed.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.

• Brand Name: PureSee IOL
• Common Device Name: LENS, INTRAOCULAR, TORIC OPTICS
• 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: 50421502
• Report Number: 3012236936-2026-000251
• Device Sequence Number: 9634502
• Product Code: MJP
• UDI-Device Identifier: 05050474819023
• UDI-Public: (01)05050474819023(17)290201
• Combination Product (Y/N): N
• Initial Reporter State: KY
• Initial Reporter Country: US
• PMA/510(K) Number: P980040
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2026
• 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,Followup
• Report Date (Section B): 09/24/2026

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?: No
• Operator of Device: Health Professional
• Device Model Number: DET150
• Device Catalogue Number: DET150U195
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 08/31/2026
• 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: 08/13/2026
• Supplement Date Received by Manufacturer: 09/11/2026
• Initial Report FDA Received Date: 08/24/2026
• Supplement Report FDA Received Date: 09/24/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/01/2026
• 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 Age: 54 YR
• Patient Sex: Female