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

Model Number	DCB00
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Blurred Vision (2137); Posterior Capsule Opacification (4807)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Section h3, device evaluated by manufacturer: the device was not returned for evaluation as it remains implanted.Therefore, a failure analysis of the complaint device cannot be completed.A review of the device history record and complaint trending for this device will be performed.Upon completion of the review, if there is any further relevant information a supplemental medwatch will be filed.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.
Event or Problem Description
The following event was reported regarding a johnson & johnson (j&j) intraocular lens (iol).The patient¿s cousin reported that the patient underwent bilateral implantation of j&j intraocular lenses and subsequently developed significant vision issues approximately three weeks postoperatively.This report pertains to the right eye.The patient reported experiencing blurred vision in lighted conditions, inability to see at night, and increasing difficulty performing daily farming activities, including operating machinery and driving, which has impacted the patient¿s independence and safety.The patient resides in a farming community.The patient¿s physician reportedly advised waiting six months to undergo a laser procedure due to the development of a film over the patient¿s eyes.The reporter expressed dissatisfaction with local ophthalmic care practices, stating that optometrists, rather than ophthalmologists, are directing patient care.The reporter further indicated that patients may not always consult directly with surgeons prior to procedures.Additionally, the reporter expressed concern that other individuals in the local farming community may have experienced similar vision issues and questioned whether there could be a potential issue with the lens.The reporter inquired about studies related to the dcb00 lens and was informed that the lens is approved by the united states food and drug administration (fda), with product information available publicly.The reporter also indicated a willingness to escalate the matter to the media or pursue legal action if concerns were not addressed.The reporter declined to provide additional information unless further discussions could occur with higher-level j&j management.A j&j supervisor subsequently conducted a follow-up call with both the reporter and the patient.During this call, additional details regarding the event were obtained, and the patient¿s experience was confirmed.The discussion concluded with an assurance that the complaint would continue to be monitored and that the reporter would provide updates if the patient¿s condition changed.No product return was requested, as the device remains implanted.The dcb00 lens and its regulatory status were referenced.No additional information is available at this time.Right eye manufacturer report number.Left eye manufacturer report number 3012236936-2026-0001734.

• 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: 25446752
• Report Number: 3012236936-2026-000167
• Device Sequence Number: 9557177
• Product Code: HQL
• UDI-Device Identifier: 05050474636125
• UDI-Public: (01)05050474636125(17)281024
• Combination Product (Y/N): N
• 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: Consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 06/09/2026

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: DCB00
• Device Catalogue Number: DCB0000220
• 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: 05/15/2026
• Initial Report FDA Received Date: 06/09/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/24/2025
• 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: Other
• Patient Sex: Male