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

Model Number	Z9002
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/18/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
If implanted; give date: n/a (not applicable).Lens was removed/replaced during the same procedure.If explanted; give date: n/a (not applicable).Lens was removed/replaced during the same procedure.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.
Event or Problem Description
It was reported that the trailing haptic of a tecnis monofocal intraocular lens (iol) got stuck, but then released and was torn in the patient's right (od) eye.The iol was removed from the eye and the procedure was completed successfully with a backup lens of the same model and diopter.There was no injury to the patient.The patient was reported to be doing ok post-op.No further information is available.
Additional Manufacturer Narrative
Additional information: section d9: device available for evaluation: yes.Section d9: return to manufacturer: 4/15/2021.Section h3: device evaluated by manufacturer: yes.Device evaluation: visual inspection under magnification revealed viscoelastic residue on the optic body and haptics, which is consistent with a lens that was handled during removal and replacement.The lens was cleaned, and a torn optic body and scratches were observed, which can be attributed to handling and cannot be confirmed to be related to manufacturing.The complaint issue could not be confirmed, and no product deficiency could be identified.Manufacturing records review: the manufacturing records for the product were reviewed.The product was manufactured and released according to specifications.Historical data analysis: a search of complaints revealed one other complaint has been received for this production order number, but it was not related to this complaint.Conclusion: as a result of the investigation, there is no indication of a quality product deficiency and the reported issue could not be verified.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.

• Brand Name: TECNIS CL IOL
• Common Device Name: INTRAOCULAR LENS
• Manufacturer (Section D): AMO PUERTO RICO MFG. INC.; road 402 north, anasco ind. pk; anasco PR 00610
• MDR Report Key: 11506853
• Report Number: 2648035-2021-07409
• Device Sequence Number: 16858025
• Product Code: HQL
• UDI-Device Identifier: 05050474530775
• UDI-Public: (01)05050474530775(17)250917
• Combination Product (Y/N): N
• Initial Reporter State: MS
• Initial Reporter Country: US
• PMA/510(K) Number: P880081
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/14/2021

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 Expiration Date: 09/17/2025
• Device Model Number: Z9002
• Device Catalogue Number: Z900200240
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/15/2021
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 02/18/2021
• Supplement Date Received by Manufacturer: 04/19/2021
• Initial Report FDA Received Date: 03/17/2021
• Supplement Report FDA Received Date: 05/14/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: SILVER CARTRIDGE LOT# UNKNOWN