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.Johnson and johnson performed follow-up to confirm if the location of the crack was at the tip.The doctor said the cartridges are cracking on the side.It¿s a hairline crack but she can see it.When the doctor starts to inject the lens that¿s when the side of cartridge cracks.The johnson and johnson investigation was completed on jul 10, 2026.The suspect product was received and evaluated.The cartridge tip was observed to be stretched.Because the cartridge was initially reported to have split during patient contact and the investigation confirmed damage to the cartridge tip, this event became reportable based on the investigation results.No further information is available.
Additional Manufacturer Narrative
Additional information: section a4, a5, a6, patient information: unknown/not provided.Section d6a, if implanted, give date: not applicable as the cartridge is not an implantable device.Section d6b, if explanted, give date: not applicable as the cartridge is not an implantable device, therefore not explantable.Device evaluation: 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 product was received.The simplicity was evaluated.The evaluation revealed ophthalmic viscosurgical device (ovd) residue in the device.No issues were observed with device assembly, pushrod tip, and lens module.No hairline crack was observed in the cartridge tip.A stretch was observed on the cartridge tip but no void or break was observed.The cartridge was subjected to dye stain testing revealing no gaps in the dye stain.Based on the complaint investigation results, the product was released within specifications.Manufacturing records review: the manufacturing records for the product were reviewed.The product was manufactured and released according to specification.A search of complaints related to this production order (po) was performed.The search revealed that no additional complaints were received for this po.No escalation was required.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.This report was impacted by emdr scheduled maintenance occurring july 22-27, 2026.

• 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: 50031933
• Report Number: 3012236936-2026-000220
• Device Sequence Number: 21447799
• Product Code: HQL
• UDI-Device Identifier: 05050474636071
• UDI-Public: (01)05050474636071(17)280723
• 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
• 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): 07/26/2026

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: DCB00
• Device Catalogue Number: DCB0000195
• Was Device Available for Evaluation?: Yes
• 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: 07/10/2026
• Initial Report FDA Received Date: 07/27/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/23/2025
• 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 Age: 79 YR
• Patient Sex: Female