MAUDE Adverse Event Report: AMO PUERTO RICO MFG. INC. TECNIS SIMPLICITY; INTRAOCULAR LENS

Model Number	DCB00
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Glaucoma (1875); Visual Impairment (2138)
Date of Event	12/09/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Section a3, a4, and a5: per regulation (b)(4) (general data protection regulation), patient identifiers were not collected or recorded and therefore are not available.Section e1 - telephone number: (b)(6).Section h3 - the intraocular lens (iol) was not returned for evaluation as it was discarded.Therefore, a failure analysis of the complaint device could not be completed.A review of the device history record, complaint trending, and risk documentation for this device will be performed.Upon completion of the review and possible product return and evaluation, if there is any further relevant information a supplemental medwatch will be filed.All pertinent information available to johnson and johnson surgical vision, inc.Has been submitted.
Event or Problem Description
It was reported that after the preloaded intraocular lens (iol) was implanted, there was an unexpected post-operative refraction.Account indicated that the surgery was completed without any complications.Target refraction: 0 pre-operative refraction: +7.5 -1.75 at 172 degrees post-operative refraction on (b)(6) 2024: ra -2.75 -2.5 at 158 degrees = 0.4 the patient experienced a glaucoma attack with a very shallow anterior chamber.A post yttrium aluminum garnet (yag-ie) cataract surgery was performed to prevent further glaucoma attacks.The patient is amblyopic, and myopia cannot be maintained according to the surgeon.Through follow-up visits, it was learned that the patient developed glaucoma after the surgery.The iol was explanted on (b)(6) 2024 and replaced with a dcb00 model iol of 24 diopter, serial number (b)(6).The explanted iol was discarded.Currently, there is no new information on the post-operative visual acuity.No further details were provided.

• Brand Name: TECNIS SIMPLICITY
• 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: 21214069
• Report Number: 3012236936-2025-000017
• Device Sequence Number: 8639934
• Product Code: HQL
• UDI-Device Identifier: 05050474636316
• UDI-Public: (01)05050474636316(17)260826
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: P980040
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Device Explanted Year: 2024
• 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
• Report Date (Section B): 01/22/2025

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 Expiration Date: 08/26/2026
• Device Model Number: DCB00
• Device Catalogue Number: DCB0000315
• 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: 01/08/2025
• Initial Report FDA Received Date: 01/22/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 08/26/2023
• 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: 57 YR
• Patient Sex: Unknown