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 Code	Endophthalmitis (1835)
Date of Event	06/12/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a patient developed endophthalmitis in the left eye following implantation of a monofocal one-piece intraocular lens (iol).Additional information indicated that a culture was performed and yielded a positive result, with enterococcus faecalis (4+ growth) identified.The infection was reported to be recurrent in nature, resulting in explantation of the iol on (b)(6) 2026.Prior to explantation, the symptoms reportedly significantly interfered with the patient's daily activities.The lens was not replaced.The patient was reported to be aphakic and experiencing corneal edema and intraocular inflammation, with silicone oil fill present and vision reported as counting fingers.The current treatment plan is to await clearance of the infection.During the cataract procedure, topical treatment was reported.No subconjunctival, systemic, or intraocular treatment was reported, and no unplanned vitrectomy was required.No over-the-counter medications were reported.Information regarding prescribed medications was not provided.The reporter indicated that no pattern had been observed among similar cases and stated that the cause of the endophthalmitis was uncertain.No johnson & johnson reusable products were involved in the procedure.The explanted device was not available for return.No further information was provided.
Additional Manufacturer Narrative
Device evaluation: product evaluation was not performed because the product was not received (the lens was discarded).The complaint issue reported could not 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.All pertinent information available to johnson & johnson surgical vision, inc., has been submitted.

• 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 ; +1(714)247-8552
• MDR Report Key: 50181834
• Report Number: 3012236936-2026-000235
• Device Sequence Number: 9886573
• Product Code: HQL
• UDI-Device Identifier: 05050474636125
• UDI-Public: (01)05050474636125(17)280904
• Combination Product (Y/N): N
• Initial Reporter State: WA
• 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,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 08/07/2026

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: DCB00
• Device Catalogue Number: DCB0000220
• 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: 07/14/2026
• Initial Report FDA Received Date: 08/07/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/04/2025
• 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: 75 YR
• Patient Sex: Female
• Patient Weight: 122 LB
• Patient Race: White