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

Model Number	DCB00
Medical Device Problem Code	Crack (1135)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/09/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the preloaded johnson and johnson (jnj) intraocular lens (iol) was implanted into the patient¿s eye.However, the side of the cartridge split during the insertion process.Reportedly, the iol was implanted successfully with no patient issues.No complications such as vitrectomy, sutures, or incision enlargement.Only the cartridge is available for return.The doctor clarified that the cartridge cracked on the side.It is a hairline crack, but she can see it.When the doctor starts to inject the lens that¿s when the side of the cartridge cracks.The cartridge was returned.However, when the complaint preloaded simplicity cartridge was received it showed the cartridge tip was slightly deformed.Because the tip was deformed and it was initially reported that the device had patient contact then this case has been updated to a reportable event and the aware date is the product investigation (pi) completion date (b)(6) 2026.No further information is available.
Additional Manufacturer Narrative
Additional information: section a2, a3a, a3b, a4, a5, a6, patient information: unknown/not provided.Section d6b, if explanted, give date: not applicable as the device was not explanted.Section d9: device available for evaluation? yes.Section d9: date returned to manufacturer: feb 25, 2026.Section h3: evaluated by manufacturer? yes.Device evaluation: the complaint device simplicity preloaded cartridge was received.The simplicity was visually inspected revealing the cartridge tip was slightly deformed.Ophthalmic viscosurgical device (ovd) was observed inside the cartridge.The lens plunger rod lens module, handpiece, and plunger rod advancement were inspected, and no issues were identified.Based on the complaint investigation results, the product was released within specifications.Conclusion: as a result of the investigation there is no indication of a product quality deficiency, and the reported issue could not be verified.Attempt was made to obtain the missing information.However, it was not provided.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: 24948917
• Report Number: 3012236936-2026-000105
• Device Sequence Number: 20153562
• Product Code: HQL
• UDI-Device Identifier: 05050474636163
• UDI-Public: (01)05050474636163(17)281106
• Combination Product (Y/N): N
• Initial Reporter State: MN
• Initial Reporter Country: US
• PMA/510(K) Number: P980040
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2026
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 04/22/2026

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: DCB00
• Device Catalogue Number: DCB0000240
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/25/2026
• 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: 04/01/2026
• Initial Report FDA Received Date: 04/22/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/06/2025
• 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: Unknown