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

Model Number	DIB00
Medical Device Problem Code	Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the preloaded monofocal lens experienced issues with stuck haptics during delivery into the eye, taking approximately 15 minutes to unfold the haptics that were adhered to the optic.However, the iols have been implanted without any issues.No further information is available.
Additional Manufacturer Narrative
Section a2, a3, a4, a5, a6: unknown/ asked but not available.Section b3: date of event: unknown, information not provided.Section d6a: if implanted, give date: unknown, information not provided section d6b: if explanted, give date: not applicable, as it is remained implanted section h3: the device was not returned for evaluation.Therefore, a failure analysis of the complaint device cannot 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, if there is any further relevant information a supplemental medwatch will be filed.Attempts have been made to obtain missing information; however, to date, no response has been received.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.
Additional Manufacturer Narrative
Additional information: after further investigation it was identified that this product was part of a production order for which outstanding product was voluntarily recalled.The voluntary recall was limited in scope to lenses from the impacted production orders that were not yet implanted as the issue only presents during procedure and hence there is no further risk to patient safety for implanted lenses.Johnson & johnson surgical vision (jjsv) initiated a field action related to tecnis® eyhance iol (intraocular lens) with tecnis simplicity¿ delivery system (dib00) due to an occurrence of sticky haptics or an unfolding issue.Use of these impacted iols may result in an occurrence of haptics sticking to the optic, which can prevent the lens from unfolding as expected following lens insertion during the surgical procedure.This occurrence has the potential to create a delay in surgery or make implantation more difficult requiring additional surgical steps, such as removal and replacement of the lens.This issue may cause adverse effects, including but not limited to corneal edema and anterior capsule tear.Although unlikely, it can also cause permanent serious injury, including but not limited to corneal damage, which may result in greater than 2 lines loss of best spectacle corrected visual acuity (bscva), despite medical surgical intervention.This issue does not impact all lenses and does not impact lenses already implanted without a complaint.Complaints will continue to be monitored and investigated.Investigation is ongoing and corrective action will be implemented as appropriate.All pertinent information available to johnson and 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: 21023664
• Report Number: 3012236936-2024-000341
• Device Sequence Number: 8367738
• Product Code: HQL
• UDI-Device Identifier: 05050474731776
• UDI-Public: (01)05050474731776(17)270118
• Combination Product (Y/N): N
• 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: Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 02/26/2026

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: DIB00U0210
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/05/2024
• Supplement Date Received by Manufacturer: 02/03/2026
• Initial Report FDA Received Date: 12/26/2024
• Supplement Report FDA Received Date: 02/26/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 01/17/2024
• 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
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: 3012236936-02-03-26-R-00
• Patient Sequence Number: 1
• Patient Sex: Unknown