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

Model Number	DIB00
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Eye Injury (1845); Blurred Vision (2137); Visual Impairment (2138)
Date of Event	11/12/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Section a4, a5 and a6: unknown, information was requested but not provided.Section h3: the device was not returned for evaluation; 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 a preloaded monofocal intraocular lens (iol) was fully inserted into the right eye of a patient.During the post-operative examination, an issue was identified, necessitating a secondary surgery for lens explantation.The reason for explant was not specified.A replacement lens of the same model but lower diopter (13.50d) was used.There was no surgical delay in procedure and no complications, such as incision enlargement, sutures, or vitrectomy reported.No medical attention or medication outside of the standard of care was required.The patient daily activities were not affected.The patient has fully recovered.Directions for use were followed.No further information provided.
Additional Manufacturer Narrative
Additional information: section d9: device available for evaluation: yes.Section d9: returned to manufacturer on: jan 13, 2026.Section h3: device evaluated by manufacturer: yes.Device evaluation: visual inspection revealed that the lens was received coated in viscoelastic residue.The lens was cleaned revealing no issues that could cause or contribute to the complaint issue.The physical characteristics of the received lens was confirmed to match that of a dib00 model lens.No issues that could cause or contribute to the complaint issues reported were identified during product evaluation.Conclusion: based on the investigation, no malfunction or product deficiency was identified.All pertinent information available to johnson & johnson surgical vision, inc., has been submitted.
Additional Manufacturer Narrative
Additional information: the following fields were updated accordingly based on the additional information received: section a5: ethnicity: non-hispanic/latino section a6: race: white section b5: additional information received indicated that the reason for explant was that the patient had blurred vision; vision was over corrected.The pre and post operative refractions are unknown, but target was 20/20.The account does not know if the device caused or contributed to the event.It is unknown if there was a loss of 2 or more lines of bscva (best spectacle corrected visual acuity) and if the patient had any pre-existing condition.No patient injury or complications such as capsule tear reported.The post op refraction after the lens exchange is unknown.Section e1: initial reporter first & last name and title: dr.Jason darlington section e2: healthcare professional: yes section e3: occupation: physician the following additional codes were added based on the additional information received: section h6: health effect - impact code: 4613 - minor injury/ illness / impairment section h6: health effect - clinical code: 2138 - visual impairment section h6: health effect - clinical code: 2137 - blurred vision corrected data: the following code is no longer applicable: section h6: health effect - clinical code: 1845 - eye injury 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 ; 7142478552
• MDR Report Key: 24064062
• Report Number: 3012236936-2026-000017
• Device Sequence Number: 9380828
• Product Code: HQL
• UDI-Device Identifier: 05050474731639
• UDI-Public: (01)05050474731639(17)281017
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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: 2025
• 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,Followup
• Report Date (Section B): 03/06/2026

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: DIB00
• Device Catalogue Number: DIB00U0140
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• 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: 12/19/2025
• Supplement Date Received by Manufacturer: 01/15/2026; 02/10/2026
• Initial Report FDA Received Date: 01/13/2026
• Supplement Report FDA Received Date: 02/05/2026; 03/06/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/17/2025
• 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: 69 YR
• Patient Sex: Female
• Patient Ethnicity: Non Hispanic
• Patient Race: White