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

Model Number	DIB00
Medical Device Problem Code	Scratched Material (3020)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Section a2 date of birth: unknown/not provided.Section a5, ethnicity: unknown/not provided.Section b3, date of event: the exact date is unknown.Based on the reported information the incident occurred sometime in april.Section d6a, if implanted, give date: not applicable, although the iol may have touched the eye, there is no indication the lens was implanted.Section d6b, if explanted, give date: not applicable.There is no indication the lens was implanted.Therefore, it was not explanted.Section h3, device evaluated by manufacturer: the device has not been returned for evaluation.Therefore, a failure analysis of the complaint device cannot be completed.A review of the device history record 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 the missing information.However, to date, it has not been received.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.
Event or Problem Description
The following was initially reported regarding the preloaded johnson and johnson (jnj) intraocular lens (iol).After the iol was injected into the left eye and the haptics unfolded, the customer saw a scratch/defect on the lens.Irrigation and aspiration (ia) was used to check if it was debris.The customer stated it was definitely a defect.However, through follow-up the customer explained that the preloaded lens was stuck inside the injector and was not able to be implanted.The iol was removed and the procedure was completed successfully with a replacement lens of the same model.The customer continued to explain that since this was a lens exchange case sutures were used as it is standard practice after iol removal.The use of sutures was not related to the damaged lens.There was no vitrectomy required.Reportedly, their operative notes do not suggest any future issues.There were no further issues.Johnson and johnson is performing follow-up to get clarification on the reported event.When information is received a supplemental report will be 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: 25024219
• Report Number: 3012236936-2026-000115
• Device Sequence Number: 13055444
• Product Code: HQL
• UDI-Device Identifier: 05050474731813
• UDI-Public: (01)05050474731813(17)280917
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: P980040
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/29/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: DIB00
• Device Catalogue Number: DIB00U0225
• 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: 04/10/2026
• Supplement Date Received by Manufacturer: 06/17/2026
• Initial Report FDA Received Date: 04/28/2026
• Supplement Report FDA Received Date: 06/29/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/17/2025
• 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
• Patient Sex: Male
• Patient Weight: 89 KG
• Patient Race: Black Or African American