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

Model Number	ZCB00
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	12/19/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the monofocal intraocular lens (iol) was found to be cracked which was noticed on insertion of the iol into a patient's right eye.The fully inserted lens was removed and replaced with another lens of the same diopter.The incision was enlarged, but no delay in procedure reported and no medical or surgical interventions were necessary.It was noted that the lens was not stuck in the cartridge.The issue did not affect patient's daily activities.The patient fully recovered from the procedure and no complications were reported.The product was discarded after use.No other information was provided.
Additional Manufacturer Narrative
Section a6: race: unknown, information was requested but not provided.The patient refused to disclose this information.Section d6a: if implanted, give date: not applicable, as lens was removed/replaced during the same procedure.Section d6b: if explanted, give date: not applicable, as lens was removed/replaced during the same procedure.Section h6: health effect - impact code: 4625 - additional surgery (incision enlargement).Section h6- health effect - clinical code 4581: no code available (incision enlargement).Device evaluation: the product testing could not be performed as the product was not returned for evaluation (the device was discarded).The reported complaint cannot be confirmed.Manufacturing record review: the manufacturing records for the product were reviewed.The product was manufactured and released according to specifications.A search of complaints related to this production order (po) was performed.The search revealed that no other complaints were received for this po.Conclusion: based on the investigation, no malfunction or product deficiency was identified.An attempt was made to obtain missing information; however, the information was not available.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 ; 7142478552
• MDR Report Key: 21329398
• Report Number: 3012236936-2025-000033
• Device Sequence Number: 20812881
• Product Code: HQL
• UDI-Device Identifier: 05050474531734
• UDI-Public: (01)05050474531734(17)280802
• Combination Product (Y/N): N
• Initial Reporter State: CT
• 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): 02/06/2025

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: ZCB00
• Device Catalogue Number: ZCB0000210
• 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: 01/14/2025
• Initial Report FDA Received Date: 02/06/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/02/2024
• 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
• Patient Sequence Number: 1
• Patient Age: 78 YR
• Patient Sex: Female
• Patient Weight: 73 KG
• Patient Ethnicity: Non Hispanic