MAUDE Adverse Event Report: AMO PUERTO RICO MFG. INC. UNK_MONOFOCAL IOL; INTRAOCULAR LENS

Model Number	DRN00V
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Visual Disturbances (2140); Halo (2227)
Date of Event	01/06/2026
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Section a2, a3a, a3b, a4, a5 & a6: unknown/ requested but not provided.Section d4: model number: unknown, as the serial number was not provided.Section d4: catalog number: unknown, as the serial number was not provided.Section d4: serial number: unknown/not provided.Section d4: expiration date: unknown, as the serial number was not provided.Section d4: unique identifier (udi) number: unknown, as the serial number was not provided.Section h3: the device was not returned for evaluation as it was discarded; therefore, a failure analysis of the complaint device cannot be completed.A review of records including device history and complaint trending will be performed.Upon completion of the review, if there is any further relevant information a supplemental medwatch will be filed.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.
Event or Problem Description
It was reported that the preloaded monofocal intraocular lens (iol) was explanted due to visual disturbances, specifically halos.The lens was not removed on the same day it was implanted.The explanted lens was replaced with a non¿johnson & johnson lens of a different model and diopter.No patient injury was reported, and no additional surgical or medical interventions such as incision enlargement, vitrectomy, or sutures were required.The patient¿s outcome was described as fine.The lens is not available for return, as it was discarded.No further information was provided.
Additional Manufacturer Narrative
Additional information: additional information was received confirming that the patient did not have any pre-existing conditions that could have affected the iol power calculation.Patient demographic details, including date of birth, age at the time of the event, sex, gender, ethnicity, and race, were provided.Device information, including model number, catalog number, serial number, expiration date, and udi, was also supplied.Accordingly, sections a2, a3a, a3b, a5, a6, and d4 have been updated in this supplemental report.No further information was provided.The following fields were updated accordingly: section a2: date of birth: (b)(6) 1952.Section a2: age: 73 years.Section a3a: sex: male.Section a3b: gender: cisgender man/boy.Section a5: ethnicity: not hispanic/ latino.Section a6: race: white.Section d4: model number: drn00v.Section d4: catalog number: drn00v0145.Section d4: serial number: (b)(6).Section d4: expiration date: aug 1, 2027.Section d4: udi number: (b)(4).Section h4: device manufacture date; aug 1, 2024.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.

• Brand Name: UNK_MONOFOCAL 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 ; 7142478552
• MDR Report Key: 24250970
• Report Number: 3012236936-2026-000029
• Device Sequence Number: 9970910
• Product Code: HQL
• UDI-Device Identifier: 05050474810655
• UDI-Public: (01)05050474810655(17)270801
• Combination Product (Y/N): N
• Initial Reporter State: DE
• Initial Reporter Country: US
• PMA/510(K) Number: P980040
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• Device Explanted Year: 2026
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 02/27/2026

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?: No
• Operator of Device: Health Professional
• Device Model Number: DRN00V
• Device Catalogue Number: DRN00V0145
• 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: 01/09/2026
• Supplement Date Received by Manufacturer: 02/04/2026
• Initial Report FDA Received Date: 02/03/2026
• Supplement Report FDA Received Date: 02/27/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 08/01/2024
• 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 Age: 73 YR
• Patient Sex: Male
• Patient Ethnicity: Non Hispanic
• Patient Race: White