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

Model Number	Z9002
Medical Device Problem Code	Material Fragmentation (1261)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/16/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
If implanted, give date: unknown, information not provided.If explanted, give date: unknown, information not provided.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.
Event or Problem Description
It was reported that the back haptic of the intraocular lens (iol) tore off during insertion.The surgeon removed the lens and replaced with another lens of same model and diopter which went fine.The event was observed when inserting into the eye.No further information was available.
Additional Manufacturer Narrative
Additional information: section a2: age/date of birth: (b)(6) 1954.Section b5: additional information received revealed that lens was not in contact with the eye, but, only the cartridge tip made contact with the patient's eye.However, there was no injury and no medical/ surgical intervention was required.The procedure was completed using another lens sn (b)(6) as replacement.Section d9: device available for evaluation: yes.Section d9: returned to manufacturer on: may 6, 2021.Section h3: device returned to manufacturer: yes.Device evaluation: the product was returned to the manufacturing site for evaluation.Visual inspection under magnification revealed viscoelastic residue on the optic body and haptic and that the lens was received cut in half (but not separated), which is consistent with a lens that was handled during removal and replacement.Furthermore, a detached haptics was observed.The complaint issue was confirmed, however this can be attributed to handling and cannot be confirmed to be related to manufacturing and no product deficiency could be identified.Manufacturing record review: the manufacturing records for the intraocular lens were reviewed.The product was manufactured and released according to specification.The search revealed no additional investigation request (ir) for this production order number has been received.Conclusion: as a result of the investigation there is no indication of a product quality deficiency.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: 11660290
• Report Number: 2648035-2021-07571
• Device Sequence Number: 11647166
• Product Code: HQL
• UDI-Device Identifier: 05050474530676
• UDI-Public: (01)05050474530676(17)251005
• Combination Product (Y/N): N
• Initial Reporter State: MO
• 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): 05/26/2021

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: 10/05/2025
• Device Model Number: Z9002
• Device Catalogue Number: Z900200190
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/06/2021
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 03/17/2021
• Supplement Date Received by Manufacturer: 04/28/2021
• Initial Report FDA Received Date: 04/13/2021
• Supplement Report FDA Received Date: 05/26/2021
• 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: CARTRIDGE MODEL: SILVER LOT NUMBER: CH11920.