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

Model Number	ZCB00
Medical Device Problem Codes	Break (1069); Material Fragmentation (1261)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/07/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
If implanted; give date: not applicable as lens was removed and replaced.If explanted; give date: not applicable as lens was removed and replaced.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.
Event or Problem Description
It was reported that a zcb00 intraocular lens (iol) was fully inserted in the patient's left eye (os), due to a bent/broken haptic.The haptic broke off during insertion.The lens was replaced with another lens of the same model and diopter.The patient has recovered.No further information available.
Additional Manufacturer Narrative
Device evaluation: product evaluation cannot be performed as the lens is not available.The complaint issue reported could not be verified and no product deficiency could be identified.Manufacturing records review: the manufacturing records review shows that the units were released within specification.No non-conformance/exception report (nc/er) was found as part of this manufacturing records review.The search revealed that no other complaints have been received for this production order.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.
Additional Manufacturer Narrative
Corrected data: upon review it was observed that the device code initially provided 1069 is being updated to 1261 to capture the reported detached haptic.H6.Medical device problem code, changed from 1069 to 1261.Additionally, the patient's date of birth was provided.A2.Date of birth, (b)(6), 1943 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
• MDR Report Key: 11775193
• Report Number: 2648035-2021-07752
• Device Sequence Number: 11844863
• Product Code: HQL
• UDI-Device Identifier: 05050474531826
• UDI-Public: (01)05050474531826(17)240930
• Combination Product (Y/N): N
• Initial Reporter State: KS
• 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: distributor,health profession
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 07/02/2021

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: 09/30/2024
• Device Model Number: ZCB00
• Device Catalogue Number: ZCB0000255
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 04/05/2021
• Supplement Date Received by Manufacturer: 05/07/2021; 06/06/2021
• Initial Report FDA Received Date: 05/05/2021
• Supplement Report FDA Received Date: 06/04/2021; 07/02/2021
• 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: PLATINUM CARTRIDGE LOT# UNKNOWN; PLATINUM CARTRIDGE LOT# UNKNOWN
• Patient Age: 77 YR