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

Model Number	DET225
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Eye Injury (1845)
Date of Event	07/27/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a preloaded extended depth of focus (edof) toric intraocular lens (iol) implanted in the patient's right eye was explanted and replaced with a preloaded multifocal intraocular lens (iol) of a different model and power (+17.5d).The lens exchange was performed to change the implanted lens from model det225 (+17.0d, cylinder 2.25d) to a multifocal lens.No unplanned surgical intervention or procedural complication was reported in association with the lens exchange.It is unknown whether the patient experienced limitations in daily activities, a loss of two or more lines of best spectacle-corrected visual acuity (bscva), overcorrection, under correction, or any adverse outcome following the procedure.The patient's current clinical status and outcome are unknown.No further information was provided.
Additional Manufacturer Narrative
Section a4, a5 and a6: unknown, information was requested but not provided.Device evaluation: the product testing could not be performed as the product was not returned.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 po.  conclusion:  as a result of the investigation there is no indication of a product quality deficiency, and the reported issue could not be verified.Attempts were made to obtain missing information; 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: 50927055
• Report Number: 3012236936-2026-000285
• Device Sequence Number: 18822694
• Product Code: MJP
• UDI-Device Identifier: 05050474819566
• UDI-Public: (01)05050474819566(17)290115
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• 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: Health Professional,User Facility
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 09/29/2026

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: DET225
• Device Catalogue Number: DET225U170
• 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: 09/03/2026
• Initial Report FDA Received Date: 09/29/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/15/2026
• 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: 70 YR
• Patient Sex: Male