MAUDE Adverse Event Report: AMO Puerto Rico Mfg. Inc. TECNIS IOL; Intraocular Lens

Model Number	ZA9003
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	02/02/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a fully implanted three-piece spherical monofocal intraocular lens (iol) was found to be dislocated on the left eye.The patient symptoms was noted to have persisted for approximately 7.5 years.The issue was observed during a postoperative examination conducted during a site visit.The original lens was subsequently explanted during a secondary surgery and was replaced with a ar40e monofocal intraocular lens (iol) with a +22.0d.No unplanned surgical interventions such as, incision enlargement, sutures, or vitrectomy were required.Directions for use was followed.The patient has fully recovered.The patient was fully recovered.No further information was provided.
Additional Manufacturer Narrative
Device evaluation: product evaluation was not performed because the product has not been received.The complaint issue reported could not be confirmed.Manufacturing record review: the manufacturing records for the product were reviewed.The product was manufactured and released according to specifications.A search in the complaint system revealed that no other complaints were received for this production order number.Conclusion: based on the investigation, no malfunction or product deficiency was identified.Attempts were made to obtain the missing information; however, no additional information has been received.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.

• Brand Name: TECNIS IOL
• 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: 50553966
• Report Number: 3012236936-2026-000252
• Device Sequence Number: 10588590
• Product Code: HQL
• UDI-Device Identifier: 05050474529069
• Combination Product (Y/N): N
• Initial Reporter State: WA
• Initial Reporter Country: US
• PMA/510(K) Number: P990080
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted 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): 09/01/2026

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 Expiration Date: 06/06/2023
• Device Model Number: ZA9003
• Device Catalogue Number: ZA90030225
• Was Device Available for Evaluation?: No
• 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: 08/05/2026
• Initial Report FDA Received Date: 09/01/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/06/2018
• 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: Required Intervention
• Patient Sex: Female