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

Model Number	ZKB00
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Eye Injury (1845)
Date of Event	12/09/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
If implanted; give date: n/a (not applicable).The iol was removed/replaced in the initial surgery.If explanted; give date: n/a (not applicable).The iol was removed/replaced in the initial surgery.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.
Event or Problem Description
Received report indicating the intraocular lens (iol) was implanted with a non-jnj cartridge into the patient¿s right eye, but was then removed because the lens optic was cracked.The lens was removed and replaced with a non-jnj iol during the same procedure.There was some bleeding and diamox was used.Reportedly, the patient is doing well post-op.No further information was provided.
Additional Manufacturer Narrative
Section d9: device available for evaluation? yes.Section d9: date returned to manufacturer: jan 25, 2021.Section h3: returned to manufacturer? yes.Device evaluation: visual inspection under magnification revealed, viscoelastic residue on the optic body and haptics.A detached haptic, and the lens was received cut in pieces (not all pieces received).Which is consistent with a lens, that was handled during removal and replacement.Based on the return condition of the lens, no further product evaluation could be performed.The complaint issue could not be confirmed.And no product deficiency could be identified.A non-johnson cartridge was used with the jnj product.Per (b)(4) (dfu, tmf zkb00 and zlb00 (us), revision a), only select jnj cartridges and inserters validated by jnj (referenced in the dfu) should be used with tecnis multifocal lenses.Manufacturing record review: the manufacturing records for the product were reviewed.The product was manufactured and released according to specifications.The search revealed, one complaint folder for suboptimal results.And another complaint folder (duplicate sn) that has since been voided.These complaint issues are not related.Therefore, no escalations are required.Conclusion: as a result of the investigation ,there is no indication of a product quality 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 IOL
• Common Device Name: LENS, MULTIFOCAL INTRAOCULAR
• Manufacturer (Section D): AMO PUERTO RICO MFG. INC.; road 402 north, anasco ind. pk; anasco 00610
• MDR Report Key: 11143958
• Report Number: 2648035-2021-07043
• Device Sequence Number: 16301553
• Product Code: MFK
• UDI-Device Identifier: 05050474560161
• UDI-Public: (01)05050474560161(17)230912
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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): Unknown
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 02/24/2021

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?: Yes
• Operator of Device: No Information
• Device Expiration Date: 09/12/2023
• Device Model Number: ZKB00
• Device Catalogue Number: ZKB00U0240
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/25/2021
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 12/10/2020
• Supplement Date Received by Manufacturer: 01/28/2021
• Initial Report FDA Received Date: 01/09/2021
• Supplement Report FDA Received Date: 02/24/2021
• 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: ALCON CARTRIDGE
• Outcome Attributed to Adverse Event: Required Intervention